[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AHS Cancer Control Alberta\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":546},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,45,69,91,112,132,152,172,191,216,234,255,274,297,321,342,363,385,402,423,441,461,482,505,529],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100637791",false,"NCT07578519","Radiation Treatment of the Prostate That is Specially Adjusted for Each Person","DOSE ADAPTED PERSONALIZED ABLATIVE RADIOTHERAPY OF THE PROSTATE","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* NCCN risk grouping of intermediate or high risk prostate cancer\n* Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent\u002Fassent\n* Identifiable lesion within the epithelium of the prostate as determined by the treating radiation oncologist\n* Have a prostate imaging reporting and data system (PIRADS) 4 or 5 nodule noted on MRI\n* Have not received prior pelvic radiotherapy\n* Life expectancy greater than 10 years\n* ECOG performance status \\\u003C3\n* Eligible for SBRT to the prostate\n\nExclusion Criteria:\n\n* No identifiable lesion within the prostate on 3T MRI\n* Prior trans-urethral resection of the prostate\n* Non-adenocarcinoma histology\n* Meeting criteria for very high-risk risk or node positive prostate cancer\n* Active inflammatory bowel disease\n* Evidence of metastatic disease on CT or bone scan\n* Declined radiotherapy\n* Unlikely to be available for all follow-up appointments\n* Having received androgen deprivation therapy or 5-alpha reductase therapy prior to trial therapy\n* Extensive disease in the posterior prostate or aberrant anatomy that makes the safe delivery of boost irradiation not feasible\n* Unable to understand or sign a study consent form after use of interpreter if required\n* Has a relative contraindication to radiotherapy including systemic lupus erythematosus, TNM deficiency or scleroderma\n* Unable to tolerate or ineligible for mpMR imaging\n* Any condition or diagnosis, that could in the opinion of the treating physician or qualified investigator interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk","MALE","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","A number of recent studies have successfully reduced the number of radiotherapy treatments used for prostate cancer from 39 daily treatments to as little as 5 treatments. This study is designed to determine how tumors inside the prostate respond during these 5 treatments on magnetic resonance imaging (MRI) and use that information to design 2 fraction radiotherapy treatments for prostate cancer.\n\nFor these two fraction treatments, the first fraction of radiation will use extra radiation to any nodules in the prostate, and the second fraction of radiation will give extra radiation to the nodule(s) in the prostate based on how those nodules responded to the first fraction of radiation. This idea is a relatively old concept but has not been used in the treatment of cancer yet. This research includes a clinical trial that evaluates whether it is safe to design treatments like this.",[26],"Prostate Cancer",[28,29,30,31],"Radiotherapy","prostate cancer","treatment","radiation","NOT_YET_RECRUITING","2026-05-06",{"date":35,"type":36},"2026-05-11","ACTUAL",{"date":38,"type":20},"2026-06",{"date":40,"type":20},"2032-06",{"name":42,"class":43},"AHS Cancer Control Alberta","OTHER",1,{"id":46,"slug":4,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100582225","NCT06860542","Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis","Inclusion Criteria:\n\n1. Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent\u002Fassent and, in the opinion of the Investigator, comply with protocol tests and procedures\n2. Patients require histologically confirmed solid tumour undergoing immune checkpoint inhibitor (ICI) therapy\n3. Diagnosis of first documented diagnosis of Checkpoint Inhibitor Pneumonitis (CIP) made per European Society for Medical Oncology (ESMO)\u002FAmerican Society for Medical Oncology (ASCO) guidelines with severity \\>\u002Fgrade 2 by Common Terminology Criteria for Adverse Events (CTCAE)v5.0\n\n   a. Per ASCO\u002FESMO consensus guidelines, workup must include a compatible clinical picture, plus\u002Fminus supporting radiographic evidence (chest x-ray or preferably computed tomography (CT)), combined with clinical and\u002For microbiologic ruling out of alternative etiologies including infections or pulmonary disease progression. This includes a negative COVID test. Bronchoscopic sampling is not required, but can be considered.\n4. Be able to effectively operate and use budesonide delivery method (Turbuhaler®), either independently or with aid of caregiver who anticipates being able to do so throughout trial period\n5. Have adequate organ function, as judged by enrolling clinician\n6. Females of childbearing potential have a negative urine or serum pregnancy test prior to study day 1. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses for at least 1 year\n7. Females of childbearing potential are willing to use contraception or abstain from heterosexual sexual contact for the course of the study\n\nExclusion Criteria:\n\n1. Diagnosis of interstitial lung disease (ILD) active (clinically and radiologically evident) within last year prior to diagnosis of CIP\n2. Clinically suspected significant lung disease for which inhaled steroid would be standard of care (moderate asthma or severe chronic obstructive pulmonary disease (COPD)) and for which randomization to no inhaled steroids (control arm) would not represent optimal medical care. Based on enrolling physicians judgement; spirometry\u002Fpulmonary function tests are NOT required to assess this exclusion criteria.\n3. Current (within last two weeks), active (not medically able or unwilling to discontinue prior to treatment start) and regular (2 or more times per week) use of inhaled steroids (for any indication) or systemic (\\>10mg prednisone equivalent) corticosteroids (for indication other than CIP) at time of randomization\n4. Receiving systemic, non-chemotherapy immunosuppressive agent at time of randomization (hydroxychloroquine is acceptable)\n5. Use of a medication with significant interaction with inhaled budesonide (HIV protease inhibitors, ketoconazole or other potent CYP3A4 inhibitors), unless deemed required and safe by co-investigator.\n6. Known poorly controlled diabetes, defined as A1c \\>10, prior to initiation of steroids for CIP\n7. History of active and unstable systemic disease, including heart failure New York Heart Association (NYHA) III or IV, cirrhosis with Child Pugh B or C, Renal Failure with creatinine clearance (CrCl) \\\u003C30 per Cockcroft-Gault formula, or other unstable life limiting condition as determined by trial investigators\n8. Current or prior participation in a study of an investigational agent or device within 4 weeks of randomization\n9. History or current evidence of any condition, therapy, or laboratory abnormalities which might confound trial results, interfere with the patient's participation for the full duration of the trial, or otherwise causing it to be not in the best interest of the patient to participate in the trial, in the opinion of the treating investigator.\n10. Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling or child) who is directly involved with this trial, unless prospective ethics board approval (by chair or designee) is given allowing exception to this criterion for a specific patient\n11. Breastfeeding is not permitted during the duration of trial participation.","ALL",{"count":52,"type":20},94,[23],"The introduction of immune checkpoint inhibitors (immunotherapy) that stimulate our immune system to recognize and attack cancer cells has been one of the most exciting advances in oncology over the last decade. These medications are now employed across almost half of cancer types and settings, however they come with a cost. In some patients, instead of attacking cancer cells alone, the stimulated immune system damages healthy tissues (immune related adverse events), with one of the most severe and potentially deadly such complications being immune attack on the lungs, or checkpoint inhibitor pneumonitis (CIP). When treated promptly with oral or intravenous steroids, acute CIP improves in many cases, however for approximately one-fifth of patients the lung inflammation is difficult to control, resulting in recurrent shortness of breath, the need for extended courses of oral or intravenous steroids, impacting quality of life and cancer therapy decisions. The goal of the trial is to assess whether use of inhaled steroids, a type of medication commonly used in asthma patients, for one year after a first diagnosis of CIP may help the lung inflammation resolve and not return, without the repeated use of oral or intravenous medications that carry more side effects.",[56,57],"Pneumonitis","Immune-related Adverse Event",[57,59],"Checkpoint Inhibitor Pneumonitis","RECRUITING","2026-03-19",{"date":63,"type":36},"2026-03-23",{"date":65,"type":36},"2026-02-10",{"date":67,"type":20},"2030-12-01",{"name":42,"class":43},{"id":70,"slug":4,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":44},"100465832","NCT05345847","Steroid Sparing in Immune Related Hepatitis (irH)","A Study to Evaluate the Efficacy and Safety of Steroid Sparing Strategy in Immune Related Hepatitis","Inclusion Criteria:\n\n1. Patients must be 18 years of age, or older on the day of signing informed consent.\n2. Patients must be capable of providing consent to enrolment and treatment.\n3. Patients with a performance status of ECOG 0-2 will be eligible for enrolment.\n4. Patients with histologically confirmed cancer receiving anti-PD1 or anti-PDL1 monoclonal antibody ICI therapy, either alone or in combination with anti-CTLA-4 monoclonal antibody ICI therapy who develop CTCAEv5.0 grade 2 or grade 3 hepatitis that has developed on, or after, ICI therapy and is felt to be treatment related (irH). Patients must be enrolled on trial within 10 days of diagnosis of grade 2 or grade 3 hepatotoxicity.\n5. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n6. Assessment by the Roussel Uclaf Causality Assessment Method (RUCAM) ≥6 showing probable relationship between ICI and liver injury (appendix)\n\nExclusion Criteria:\n\n1. History underlying liver disease, including, but not limited to: hepatitis B, C, autoimmune hepatitis, primary biliary sclerosis, hemochromatosis, primary sclerosis cholangitis, portal vein thrombosis, Budd Chiari syndrome, alcohol induced hepatitis, suspected drug-induced liver injury from other cause (e.g. acetaminophen, antibiotics, statins, methyldopa, non-prescription herbs, see NIH LiverTox website https:\u002F\u002Flivertox.nih.gov for comprehensive list).\n2. If undertaken, liver biopsy supporting a cause of liver dysfunction other than irH\n3. Patients with an indication for systemic immunosuppressive medications or corticosteroids. Patients with CTCAEv5.0 grade ≥2 irAE's other than irH (ie. colitis, pneumonitis, rash, etc.) are not eligible for trial, with the exception of endocrinopathies that are being treated with hormone replacement alone and not systemic immunosuppressive medications or corticosteroids.\n4. Abnormal International Normalization Ratio (INR) at baseline (≥1.5) and bilirubin ≥60, ALT of ≥10X.\n5. Previous use of targeted therapies for treatment of malignancy (e.g. BRAF, MEK, EGFR, and VEGF inhibitors) or current treatment with chemotherapy\n6. Present use of warfarin.\n7. Diagnosis of immunodeficiency.\n8. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n9. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAEv5.0 Grade ≥ 3).\n10. Other severe acute or chronic medical conditions including inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",{"count":76,"type":20},56,[78],"NA","A multi-centre, randomized, non-inferiority trial in patients with irH, randomized to receive either close surveillance with corticosteroid rescue therapy or early high dose corticosteroids.",[81],"Hepatitis Immune",[83,84],"immune related hepatitis","steroid sparing",{"date":63,"type":36},{"date":87,"type":36},"2025-12-08",{"date":89,"type":20},"2029-02-08",{"name":42,"class":43},{"id":92,"slug":4,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":50,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":110,"locationsCount":111},"100421264","NCT04765514","Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients","A Randomized Controlled Trial of Chemo-Radiotherapy Versus Chemotherapy for Elderly and Frail Patients With Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n1. Newly-diagnosed, histologically proven, intracranial glioblastoma with maximal safe resection. Biopsy alone is expected if resection is not possible. MGMT promoter methylation status must be tested and the results positive (defined as all non-negative MGMT status, including intermediate or indeterminate status (i.e., with cutoff higher than the MGMT negative threshold).\n2. History and physical examination, including neurological examination, within 14 days prior to randomization.\n3. Age ≥ 65 \\& KPS of 60 - 70\n4. Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization.\n5. Laboratory evaluation within 7 days prior to randomization, with adequate function as defined below:\n\n   1. ANC ≥ 1.5 x 109\u002FL\n   2. Platelets ≥ 100 x 109\u002FL\n   3. Serum creatinine ≤ 1.5 times ULN or estimated Glomerular Filtration Rate (eGFR) \\> 59\n   4. Total serum bilirubin ≤ 30 umol\u002FL (ie ≤ 1.5 times ULN)\n   5. ALT \\\u003C 150 U\u002FL (ie \\\u003C 3 times ULN)\n   6. AST \\\u003C 120 U\u002FL (ie \\\u003C 3 times ULN)\n   7. Alkaline phosphatase \\\u003C 390 U\u002FL (ie \\\u003C 3 times ULN)\n6. Patients must sign a study-specific informed consent prior to study registration.\n7. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n   1. This will apply for male patients only and their female partner if of child bearing potential.\n   2. Effective contraception should also be used by male patients taking temozolomide. Men being treated with temozolomide are advised not to father a child during or up to 6 months after discontinuation of treatment (male patients).\n8. Male patients should agree to not donate sperm during the study treatment and for six months post treatment completion.\n\nExclusion Criteria:\n\n1. Negative MGMT promoter methylation status, or a status of not reportable.\n2. Recurrent malignant gliomas\n3. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.\n4. Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide\n5. Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study.\n6. Severe, active co-morbidity, defined as follows:\n\n   1. Unstable angina and\u002For congestive heart failure requiring hospitalization\n   2. Transmural myocardial infarction within the last 6 months\n   3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study registration\n   4. Any severe, active co-morbidity precluding delivery of temozolomide.\n   5. History of hypersensitivity reaction to temozolomide components or to dacarbazine.\n   6. Active HBV infection","65 Years",{"count":99,"type":20},107,[23],"Currently, the optimal treatment regimen for elderly Glioblastoma (GBM) patients with poor performance status (PS) is unknown. Based on data for elderly GBM patients and the limited data for patients with poor PS, hypofractionated RT or a short course of Temozolomide (TMZ) may provide survival benefit without the added toxicity and inconvenience of a more protracted treatment regimen.\n\nIn particular, treatment with RT or TMZ monotherapy on the basis of methylated O6 - methyl guanine - DNA methyltransferase (MGMT) promoter methylation status, followed by the alternative therapy at progression, may provide a safe and effective treatment regimen for patients with poor PS.\n\nThe hypothesis of this trial is that in elderly GBM patients with poor performance status (age ≥ 65 years and KPS 60-70), a chemotherapy alone (TMZ monotherapy) approach to therapy results in non-inferior overall survival compared to combined TMZ\u002FRT.\n\nIt is hypothesized that chemotherapy will result in non-inferior progression-free survival, reduced toxicity and increased cost-effectiveness compared to combined chemoradiotherapy.\n\nPrimary objective:\n\n• To compare overall survival of standard therapy vs chemotherapy in elderly and frail patients with newly diagnosed GBM.\n\nSecondary objective:\n\n* To evaluate progression-free survival following treatment in both arms.\n* To evaluate adverse events according to CTCAE criteria in both arms.\n* To evaluate health-related quality-of-life as assessed by MoCA and EORTC QLQ-C30\u002FQLQ-BN20 questionnaires in both arms.\n* To evaluate cost-effectiveness of standard therapy vs chemotherapy\n\nMethods:\n\nPatients will be randomized to two treatment groups in a 1:1 ratio. Standard Arm: Combined modality arm Chemo-radiotherapy consisting of 40 Gy in 15 daily fractions with concurrent TMZ. TMZ will be delivered at a dose of 75 mg\u002Fm2 daily for 21 days. TMZ will be administered 1 hour before each session of RT.\n\nAfter a 4-week break, patients will receive adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated by the patient. The dose will be 150 mg\u002Fm2 for the first cycle and increased to 200 mg\u002Fm2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue. If tolerated, additional cycles of adjuvant TMZ may be administered at the treating investigator's discretion according to site practice.\n\nInvestigational Arm: TMZ monotherapy Patients will receive TMZ at a dose of 75 mg\u002Fm2 daily for 21 days, followed by adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated by the patient. The dose will be 150 mg\u002Fm2 for the first cycle and increased to 200 mg\u002Fm2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue. If tolerated, additional cycles of adjuvant TMZ may be administered at the treating investigator's discretion according to site practice.\n\nUpon treatment completion, participants will be followed by every 2 and 3 months for 2 years. Response and progression will be evaluated using the new international criteria proposed by the Response Assessment in Neuro-Oncology working group (RANO).",[103],"Glioblastoma Multiforme","2026-02-11",{"date":106,"type":36},"2026-02-13",{"date":108,"type":36},"2022-07-27",{"date":40,"type":20},{"name":42,"class":43},2,{"id":113,"slug":4,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100576845","NCT06790589","COACH - Comparing Two Different Methods to Suppress Thyrotropin in Patients With Advanced Thyroid Cancer","COmparison of Two Alternative Thyrotropin Suppression Strategies Among Patients With Advanced Differentiated Cancer of the tHyroid","Inclusion Criteria:\n\n1. Minimum age of 18 years, with no upper limit of age.\n2. ECOG 0-2\n3. Patients must be capable of providing consent to enrollment and willing to comply with study treatment and follow-up.\n4. Diagnosis of differentiated thyroid cancer (including papillary, follicular, oncocytic, and poorly differentiated subtypes) with advanced structural disease (defined as unresectable persistent\u002F recurrent locoregional disease and\u002For distant metastases).\n5. Residence within Alberta and referral to the Cross Cancer Institute in Edmonton, for consideration of anticancer therapy and\u002For follow-up.\n6. Absence of any condition hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study.\n7. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those resulting in low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n\n   Note: abstinence is acceptable if this is established and preferred contraception for the patient.\n8. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n9. Females must not be breastfeeding (timeframe: during study treatment period and for a period of 30 days after the last dose of the study drug).\n10. Ability to obtain sufficient thyroid cancer tissue to conduct baseline NGS testing (could be fresh or archived tissue).\n\nExclusion Criteria:\n\n1. Recent acute coronary event (within 6 months of randomization).\n2. History of atrial fibrillation.\n3. Known hypersensitivity to levothyroxine.\n\n   \\- Treatment with other investigational drugs within 30 days prior to randomization.\n4. History of fragility fractures or established diagnosis of osteoporosis.\n\n   * Prior treatment with levothyroxine before study entry at any dose and with any TSH target is not an exclusion criterion.",{"count":119,"type":20},70,[23],"Most thyroid cancers can be cured with surgery, sometimes with radioactive iodine therapy. However, some patients have cancer that has spread, and some have cancer that comes back after treatment. For those with remaining cancer, lowering TSH levels is recommended. This is because thyroid cancer growth can depend on TSH, so reducing TSH can lower the risk of cancer returning and slow its growth in patients with cancer that can't be surgically removed.\n\nInternational guidelines recommend keeping TSH levels as low as \\\u003C0.1 mU\u002FL for patients with advanced thyroid cancer. This advice is based on past studies, but it hasn't been tested in a controlled way. One old study suggested that not lowering TSH enough could lead to more cancer relapses. Another study suggested that lowering TSH more could help prevent cancer from getting worse in high-risk patients. However, a recent study found no link between TSH levels and better outcomes, and the researchers suggested doing a new study to confirm if this practice is truly beneficial.\n\nLowering TSH levels to \\\u003C0.1 mU\u002FL using levothyroxine has been the standard of care for treating advanced thyroid cancer for a long time. The researchers would like to investigate whether using levothyroxine to keep TSH levels between 0.1 and 0.5 mU\u002FL is just as safe and effective for cancer treatment as the current recommendation of keeping it below 0.1 mU\u002FL. The researchers also believe this study can help set TSH suppression targets based on cancer type, reducing unnecessary side effects from too much TSH suppression while still achieving the same cancer treatment results.\n\nIf the researchers can prove that keeping TSH levels between 0.1 and 0.5 mU\u002FL is just as safe and effective as the standard of care practice, we can change our standard treatment approach. This would help reduce symptoms for our patients.",[123],"Advanced Differentiated Thyroid Gland Carcinoma","2026-02-04",{"date":126,"type":36},"2026-02-06",{"date":128,"type":20},"2026-12",{"date":130,"type":20},"2031-01",{"name":42,"class":43},{"id":133,"slug":4,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":44},"100471633","NCT05421416","Loratadine for the Prevention of G-CSF-related Bone Pain","Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization","Inclusion Criteria:\n\n1. A histologically or cytologically documented lymphoma or multiple myeloma\n2. Next line of therapy is autologous stem cell transplant\n3. Adult ≥ 18 years old.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n5. Life expectancy of at least 12 weeks.\n6. The absence of any additional poorly controlled systemic disease that is directly contraindicated or places subject at significant risk, including but not limited to: congestive heart failure, diabetes mellitus, cirrhosis or liver failure, renal failure.\n7. Able to adhere to study protocols and visit schedules\n\nExclusion Criteria:\n\n1. Hypersensitivity or intolerance to antihistamines\n2. Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols.\n3. Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual.\n4. New and continued regular use of analgesics within the four days prior to the first dose of G-CSF",{"count":139,"type":20},78,[23],"The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting.",[143],"Stem Cell Transplant Complications","2026-02-03",{"date":146,"type":36},"2026-02-05",{"date":148,"type":36},"2024-11-28",{"date":150,"type":20},"2026-12-01",{"name":42,"class":43},{"id":153,"slug":4,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100618358","NCT07330583","Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Oligometastatic Esophageal Cancer","Phase II Single Arm Study to Evaluate Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Management of Patients With Oligometastatic Esophageal Cancer","Inclusion Criteria:\n\n1. Age ≥ 18\n2. Eastern Cooperative Oncology Group performance status ≤ 2.\n3. Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus.\n4. Diagnosed with stage IVB disease (according to UICC TNM version 8) with up to five metastatic lesions in up to three organs.\n5. At least one metastatic lesion amenable to the delivery of SBRT.\n6. Estimated life expectancy \\>6 months.\n7. The function of important organs meet the following requirements: a. white blood cell count (WBC) ≥ 4.0×109\u002FL, absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; b. platelets ≥ 100×109\u002FL; c. hemoglobin ≥ 9g\u002FdL; d. serum albumin ≥ 2.8g\u002FdL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and\u002For AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate \\>60 mL\u002Fmin;\n8. Ability to understand the study and sign informed consent.\n9. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n10. Patients of childbearing\u002Freproductive potential should use highly effective birth control methods if indicated, as defined by the investigator, up to the period of finishing capecitabine and for 6 months after last dose. A highly effective method of birth control is defined as those that result in low failure rate (i.e., less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient.\n11. Females must not be breastfeeding while taking capecitabine or within 2 weeks after the last dose.\n12. Male patients should agree to not donate sperm during the study while taking capecitabine and for 3 months after the last dose.\n13. Male patients should not father a child while taking capecitabine and for 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment and not amenable to SBRT.\n2. Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum.\n3. Patients have spinal bone metastases combined with spinal cord compression.\n4. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.\n5. Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia.\n6. Inability to provide informed consent due to psychological, familial, social, and other factors.\n7. Female patients who are pregnant or during lactation.\n8. Active autoimmune diseases, or a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism) that precludes the use of immunotherapy as decided by the treating medical oncologist, a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation.\n9. A history of interstitial lung disease or non-infectious pneumonia; Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).",{"count":159,"type":20},22,[23],"Participants in this study will have esophageal cancer that has spread (metastasized) to other parts of the body either at initial diagnosis (synchronous) or after the cancer returned following treatment (recurrent).\n\nIn Alberta, the current standard approach for treating esophageal cancer that has metastasized is to first give patients radiation to the main tumor in the esophagus to relieve symptoms. After that, they receive a combination of chemotherapy drugs (either CAPOX or FOLFOX) chosen by their doctor, along with immunotherapy drugs like Pembrolizumab or Nivolumab to fight the cancer.\n\nThe study intends to add a treatment called stereotactic body radiation treatment (SBRT), which uses very high doses of radiation in a few sessions, to target small tumors which remain after the standard treatment.\n\nThe goal of this study is to see if adding SBRT to chemotherapy and immunotherapy helps patients with newly diagnosed or recurrent esophageal cancer that has metastasized to a few other places. The study aims to improve survival and control the disease better.",[163],"Esophageal Cancer","2025-12-29",{"date":166,"type":36},"2026-01-09",{"date":168,"type":20},"2026-03",{"date":170,"type":20},"2032-03",{"name":42,"class":43},{"id":173,"slug":4,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":44},"100231943","NCT02297217","Chemoradiotherapy for Advanced Esophageal Cancer","A Phase 2 Study of Palliative Chemo-Radiotherapy With Carbo-Taxol in Non-Curative Cancer of the Esophagus","PaRCUS","Inclusion Criteria:\n\n1. Biopsy proven carcinoma of the esophagus.\n2. Not a candidate for radical\u002Fcurative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness.\n3. Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids.\n4. ECOG Performance status ≤ 2.\n5. Patients able to begin treatment within 14 days of signing the informed consent form.\n6. Patient is at least 18 years old.\n7. Hematological function as defined by the following laboratory parameters:\n\n   * Hemoglobin \\> 100g\u002FL\n   * Platelet count \\> 100x10E9\u002FL\n   * Absolute neutrophil count \\> 1.5x10E9\u002FL\n8. Renal function to undergo chemotherapy as defined by the following laboratory parameters:\n\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x the upper limit of institutional normal (≤ 5 if liver metastases)\n   * Total bilirubin ≤ 1.5x the upper limit of institutional normal\n   * Calculated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula\n9. Patients capable of childbearing are using adequate contraception.\n10. Written and informed consent of patient.\n\nExclusion Criteria:\n\n1. Previous radiotherapy delivered to the chest.\n2. Synchronous active malignancies.\n3. Pregnant or lactating patients: women of child bearing potential must have a negative serum pregnancy test within 7 days of Treatment Visit 1. Women or men of child bearing potential must use effective contraception (defined by the use of two birth control methods, which can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy). Subjects must start using birth control from the time they have signed the Informed Consent Form prior to start of therapy until 120 days post completion of study therapy or study discontinuation, which must be documented in the eCRF.\n4. Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.\n5. Tracheo-esophageal fistula.\n6. Esophageal stents in situ.\n7. Previous chemotherapy for esophageal cancer\n8. Unable to complete surveys in English without aid of interpreter.",{"count":19,"type":20},[23],"This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a palliative course of external beam radiation treatment improves both dysphagia relief and patient quality of life in patients with unresectable esophageal cancer.",[163],"2025-12-09",{"date":185,"type":36},"2025-12-16",{"date":187,"type":36},"2019-11-21",{"date":189,"type":20},"2028-04-30",{"name":42,"class":43},{"id":192,"slug":4,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":44},"100449150","NCT05128734","Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)","A Randomized Phase II Study of Temozolomide Monotherapy or in Combination With Olaparib in Patients With METHYLATED 06-Methylguanine-DNA Methyltransferase (MGMT) Pre-Treated Triple Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n* Female or male patients with triple negative breast cancer confirmed by pathology of the primary tumour or metastatic biopsy sample. Estrogen receptor (ER) and progesterone receptor (PgR) must be ≤2 Allred score by Immunohistochemistry (IHC); human epidermal growth factor receptor 2 (HER2) 0 or 1+ by IHC, or 2+ with confirmed negativity by in situ hybridization (ISH) assay.\n* Available Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue. If archival tissue is not available, the participant will have the option to provide a fresh tumour tissue specimen from a newly obtained biopsy. If archival and fresh tissue are not available, the participants will be excluded.\n* MGMT promoter methylated by clinical assay.\n* Prior exposure to anthracyclines and taxanes in adjuvant\u002Fneoadjuvant and\u002For metastatic setting.\n* At least one line of chemotherapy in the context of metastatic disease.\n* ECOG performance status 0 or 1 (Appendix A).\n* Age ≥ 18 years old.\n* Measurable disease (at least one 1x1 cm or greater lesion evaluable by CT scan and\u002For clinically; i.e., includes clinically evaluable skin metastases). Patients with only metastases to the bone are not eligible (See Section 10 Measurement of Effect for the evaluation of measurable disease).\n* Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 4 weeks prior to start of study treatment):\n\n  * Absolute neutrophil count \\> 1.5 x109\u002FL\n  * Platelets \\> 100 x109\u002FL\n  * Serum creatinine \\\u003C 1.5 times upper limit of laboratory normal\n  * Total serum bilirubin \\\u003C 1.5 times upper limit of laboratory normal\n  * AST or ALT ≤ 2.5 times upper limit of laboratory normal\n  * Alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal\n* Each subject must be able to sign an informed consent form prior to enrollment in the trial to document their understanding and willingness to participate.\n* Subjects must be accessible for treatment and follow-up at one of the participating centres.\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method from the start of treatment until 6 months after treatment discontinuation. A woman is considered to be of \"childbearing potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy\u002Fvasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures.\n* Male patients must not donate sperm and\u002For father a child during treatment with temozolomide alone or in combination with olaparib and for at least 6 months after the final dose.\n* Women of childbearing potential will have a pregnancy test as part of the Pre-Study Evaluation within 7 calendar days prior to first study treatment.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of radiographic and\u002For clinical progression and the patient does not require ongoing use of corticosteroids. Participants with known history of CNS involvement, should have a brain imaging (CT\u002FMRI) at screening.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be \\>class 2B.\n\nExclusion Criteria:\n\n* Patients who have received chemotherapy within 4 weeks or radiotherapy to a non-target site within 2 weeks prior to entering the study or who have not recovered from adverse events from prior anti-cancer therapy (residual toxicities \\> Grade 1) with the exception of alopecia.\n* Patients who are receiving any other investigational agents within 3 weeks of signing the main informed consent form.\n* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.\n* Patients with psychiatric illness\u002Fsocial situations\u002Fsubstance abuse that would limit compliance with study requirements.\n* Pregnant, breastfeeding women, and subjects unable and\u002For unwilling to use contraception methods.\n* Patients with metastatic disease to bone only.\n* Prior treatment with Temozolomide or Olaparib.\n* Patients who are hypersensitive to any ingredients in the formulation of Olaparib, temozolomide or to dacarbazine (DTIC).\n* Known BRCA1 or BRCA2 germline mutation(s).\n* Patients with HIV, Hepatitis B, or Hepatitis C infection.\n* Inclusion of Women and Minorities: There are no exclusions based on gender, race or ethnicity in this trial. The intention, therefore, is to recruit subjects from racial\u002Fethnic groups in close approximation to the local incidence of the disease in these groups.",{"count":198,"type":20},40,[23],"This is a randomized phase II study to evaluate the disease control rate (DCR) of patients with metastatic or locally advanced METHYLATED 06-methylguanine-DNA methyltransferase (MGMT) with triple-negative breast cancer (TNBC) treated with Temozolomide ± Olaparib. Patients will be randomized 1:1 to Treatment Arm 1 (temozolomide treatment) or Arm 2 (temozolomide plus olaparib treatment).",[202],"Breast Cancer Triple Negative",[204,205,206,207,208],"METHYLATED 06-methylguanine-DNA methyltransferase (MGMT)","Triple-Negative Breast Cancer","TNBC","Temozolomide","Olaparib",{"date":210,"type":36},"2025-12-15",{"date":212,"type":20},"2026-04-01",{"date":214,"type":20},"2028-07-01",{"name":42,"class":43},{"id":217,"slug":4,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":111},"100383097","NCT04268199","A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment","EASE","Inclusion Criteria:\n\n* Patients are aged 18 years old or older with a diagnosis of symptomatic myeloma,\n* Stable clinical status as deemed by responsible investigator,\n* Personally (or caregiver) willing and deemed capable to self-administer with teaching,\n* Previously received more than 4 injections of bortezomib within the hospital and\u002For cancer centre environment,\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Currently participating in clinical trials that includes the use of bortezomib,\n* History of allergic reactions to bortezomib,\n* History of bleeding attributable to bortezomib,\n* History of greater than or equal to grade 3 side effects attributable to bortezomib,\n* Clinically deemed unlikely to be compliant with therapy by responsible investigator,\n* Life expectancy anticipated to be less than 6 months,\n* Deemed geographically inaccessible to receive care.",{"count":223,"type":20},100,[23],"This study is to see if the standard of care subcutaneous injection of bortezomib can safely be administered at home by the patient or caregiver. All tests and assessments are based on standard of care procedures.",[227,228],"Myeloma","Myeloma Multiple",{"date":210,"type":36},{"date":231,"type":36},"2020-05-29",{"date":128,"type":20},{"name":42,"class":43},{"id":235,"slug":4,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":44},"100615357","NCT07291557","PSMA-PET Directed Radiation Therapy for High-Risk Prostate Cancer","PSMA-PET Directed Radiation Therapy in High and Very High-Risk Prostate Cancer","Inclusion Criteria:\n\nPSMA-N0M0 patients who have a documented history of High Risk localized adenocarcinoma of the prostate are eligible to participate if they meet the following eligibility criteria:\n\n1. Participants capable of giving written informed consent.\n2. Male.\n3. Age ≥18 years.\n4. ECOG ≤2.\n5. Patient has histologically proven adenocarcinoma of prostate gland with an assigned Gleason score and Gleason Grade Group.\n6. ≥NCCN High-Risk localized disease as per standard imaging investigations including pelvic imaging (CT, MRI) and 99Tc bone scan. High Risk prostate cancer defined as any of the following: cT3-T4 disease OR PSA ≥20 ng\u002Fml OR Gleason grade group 4 or 5.\n7. No documentation of regional nodal (N1) or metastatic (M1) prostate cancer on standard imaging (CT, MRI, or 99Tc bone scan).\n8. In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate.\n9. Patient commits to androgen suppression treatment as per standard of care. 10. Patient is willing to complete symptom and patient reported outcome questionnaires.\n\n11\\. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of radiation therapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n\nMale patients should agree to not donate sperm during the study and for 6 months after completion of radiation therapy.\n\nExclusion Criteria:\n\n1. Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).\n2. Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance, interpretation, or compliance with radiation\n3. Patients who have initiated therapy (ADT, systemic therapy, or radiation) for their prostate cancer prior to PSMA-PET imaging.\n4. History of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations\u002Finterventions related to anorectal diseases.\n5. History of prostatectomy or previous pelvic radiotherapy.\n6. Previous malignancy within the last five years, except BCC or SCC skin or a malignancy treated curatively with no evidence of disease for ≥5 years.\n7. Bilateral hip prostheses will be ineligible for study",{"count":241,"type":20},250,[23],"In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy targeted to the prostate and nearby tissues with or without whole pelvis radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial.",[26],[28,246],"PSMA","2025-12-05",{"date":249,"type":36},"2025-12-18",{"date":251,"type":20},"2026-05",{"date":253,"type":20},"2036-05",{"name":42,"class":43},{"id":256,"slug":4,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":271,"leadSponsor":273,"locationsCount":4},"100583887","NCT06882174","This Study is Comparing Morning vs Random Scheduling of Standard of Care Pembrolizumab Checkpoint Inhibitor Immunotherapy Infusions in Patients With Metastatic Non-small Cell Lung Cancer","Timing of Immunotherapy for the Modulation of Efficacy: a Pilot Study in Metastatic Non-Small Cell Lung Cancer","TIME-NSCLC","Inclusion Criteria:\n\n1. Patients with histologic diagnosis mNSCLC with PDL1 staining ≥ 50% on standard of care IHC testing\n2. Patients must be eligible for treatment with standard-of-care pembrolizumab\n3. Patients must be 18 years of age or older.\n4. Patients must be capable of providing consent to enrolment and willing to comply with study, treatment and follow-up.\n5. Patients with a performance status of Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Oken et al., 1982) will be eligible for enrolment\n6. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 7 days prior to the first dose of pembrolizumab. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.\n7. Patients of childbearing \u002F reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n8. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n9. The following adequate organ function laboratory values must be met:\n\nHematological:\n\n* Absolute neutrophil count (ANC) \\>1.0\n* Platelet count \\>100\n* Hemoglobin \\>90 mg\u002FdL\n\nRenal:\n\no Serum creatinine \\\u003C3x upper limited of normal (ULN)\n\nHepatic:\n\n* Total serum bilirubin \\\u003C2x ULN\n* AST and ALT \\\u003C3x ULN\n\nCoagulation:\n\no International Normalized Ratio (INR) \\\u003C1.5x ULN (unless patient is receiving anticoagulant therapy and if PT or PTT is within therapeutic range of intended use of anticoagulants)\n\nExclusion Criteria:\n\n1. Concurrent therapy with systemic therapy other than pembrolizumab (such as chemotherapy, targeted therapy, other checkpoint inhibitors, or hormonal therapy).\n2. Treatment plan includes local therapy such as radiation or surgery.\n3. Untreated symptomatic brain metastases, or previously treated brain metastases requiring corticosteroids for symptom control. Patients with untreated asymptomatic brain metastases, where all lesions are \\\u003C 2cm in size with no vasogenic edema, are eligible.\n4. Presence of leptomeningeal disease.\n5. Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C. Testing for HIV, HBV or HCV is not mandatory for enrolment to study but may occur at the discretion of the investigator.\n6. Active autoimmune disease that has required systemic treatment in past 12 months (i.e. with use of disease modifying agents, requiring \\>10mg prednisone or equivalent or other immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n7. Participant unwilling to agree to their treatment times being scheduled as per study protocol during the study treatment period (Cycles 1-6).",{"count":263,"type":20},58,[23],"This clinical trial is comparing morning infusions of the study drug (pembrolizumab) to random infusion scheduling for patients with non-small cell lung cancer.\n\nParticipants will be randomized to either the Intervention (Morning Group) where Infusion start times are restricted between 0800 AM and 1000 AM or to the Control (Standard of Care) group where scheduling will occur as standard of care scheduling, in which infusions are scheduled without respect to a specific time of day.\n\nThere are past studies that suggest the timing of treatment may influence immune response and outcomes. This idea is called chronotherapy. Chronotherapy explores the notion that the timing of drug administration in relation to the body's internal clock can optimize treatment effectiveness. The timing of the infusions for the morning group was therefore, chosen based on data from these past studies that looked at circadian variation in immune system function with the intent to focus on similar infusion windows.\n\nThe aim of this study is to provide confirmation that the intervention is possible to achieve and use these results to design a larger study. Circadian timing of drug administration, if effective, would represent an intervention that could improve survival outcomes at no additional cost or apparent increase in toxicity, which is truly rare in oncology.\n\nParticipants are asked to participate in the study intervention for 18 weeks (6 cycles of pembrolizumab), after which participants would continue with ad hoc scheduling as per standard of care.",[267],"Metastatic Non Small Cell Lung Cancer","2025-12-02",{"date":87,"type":36},{"date":251,"type":20},{"date":272,"type":20},"2028-07",{"name":42,"class":43},{"id":275,"slug":4,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":21,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":44},"100442394","NCT05040815","Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer","A Prospective Phase II Study of Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer (INSPIRE)","INSPIRE","Inclusion Criteria:\n\n1. Participants capable of giving informed consent.\n2. Patients must be 18 years of age or older.\n3. Patient should have histologically proven primary squamous cell carcinoma.\n4. Patients must have early AC, Stage T1-3 N0 M0.\n5. No inguinal nodal involvement confirmed by PET imaging and SLNB.\n6. No history of prior malignancy other than non-melanoma skin cancer or other malignancy with disease free survival ≥ 5 years.\n7. Performance status ECOG 0-2 \u002F Zubrod performance status ≥70.\n8. Patient should be eligible for concomitant chemotherapy (e.g. adequate hepatic, renal and bone marrow function).\n9. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n10. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard).\n11. Females must not breastfeed during study treatment.\n12. Male patients should agree to not donate sperm during study treatment.\n13. Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration.\n\nExclusion Criteria:\n\n1. T1N0 patients going for primary surgery\n2. Prior radiation therapy to the pelvis.\n3. Pregnancy or lactation.\n4. Prior surgical treatment for anal cancer other than biopsy.\n5. Prior surgical or chemotherapy treatment for anal cancer.\n6. Evidence of distant metastases.\n7. Comorbid medical conditions precluding radical treatment at the discretion of Oncologist.\n8. Histology other than squamous cell carcinoma or variants.",{"count":282,"type":20},45,[23],"The purpose of this study is to see whether avoiding preventative radiation to the groin in patients with normal sentinel node biopsy and PET-CT, is at least as effective treating cancer as giving preventative radiation to the groin for patients with anal canal cancer.\n\nThe investigators also want to know if avoiding radiation to the groin will cause fewer side effects and better quality of life",[286],"Anal Canal Cancer",[288],"radiotherapy","2025-10-01",{"date":291,"type":36},"2025-10-02",{"date":293,"type":36},"2023-05-11",{"date":295,"type":20},"2028-05",{"name":42,"class":43},{"id":298,"slug":4,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":50,"minAge":303,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":21,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":44},"100199765","NCT01876771","A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours","An Open-label Phase II Study of Lutetium-177 [DOTA0, Tyr3] Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours","Group A (Primary Therapy) Inclusion Criteria:\n\n1. Male or female ≥ 14 - 90 years of age.\n2. At least 1 tumour site reliably evaluable by CT or magnetic resonance imaging (MRI) of at least 1.0 cm (smallest dimension) or ≥ 1.5 cm lymph node disease (smallest dimension) (the target lesion) within 26 weeks of enrolment, with documented presence of somatostatin receptors on radionuclide imaging, with uptake greater than liver background as assessed by planar Octreoscan® images or Ga-68 labelled somatostatin analogue (68Ga-DOTATATE or 68Ga-HA-DOTATATE) PET imaging (or other available somatostatin receptor targeting PET agents) obtained within 1 year of enrolment. Patients with bone-only disease can be enrolled provided there is presence of somatostatin receptor positive tumour(s) on radionuclide imaging corresponding to osteolytic or osteoblastic bone lesions on CT or MRI, with uptake greater than liver background as assessed by planar Ocgtreoscan(R) images or somatostatin receptor PET imaging regardless of size.\n3. Histologically confirmed diagnosis of neuroendocrine tumor.\n4. Progressive disease documented by anatomic imaging and\u002For presence of new lesions on somatostatin receptor imaging assessed by comparable studies. In the opinion of the investigator, patients with no progression on imaging may still be considered eligible in presence of carcinoid symptoms refractory to treatment with somatostatin receptor analogues or functional Pheochromocytoma\u002FParaganglioma symptoms that are not well controlled with current medical treatment.\n5. 18F-FDG PET\u002FCT whole-body imaging within 26 weeks of enrolment.\n6. Life expectancy greater than 12 weeks from enrollment.\n7. Serum creatinine ≤ 150 µmol\u002FL, and a calculated (Cockcroft-Gault) or estimated GFR of ≥ 50 mL\u002Fmin measured within 2 weeks of enrollment.\n8. Haemoglobin concentration ≥ 90 g\u002FL; white blood cell (WBC) count ≥ 2 x 10\\^9\u002FL; platelets ≥ 100 x 10\\^9\u002FL measured within 2 weeks of enrolment.\n9. Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST)) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g\u002FL within 2 weeks of enrolment.\n10. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment.\n11. Provide written informed consent prior to enrolment.\n\nGroup B (Maintenance Therapy) Inclusion Criteria:\n\n1. Male or female ≥ 14 - 90 years of age.\n2. Have previously received Lu-DOTA-TATE treatment under the SAP.\n3. Life expectancy greater than 12 weeks from enrolment.\n4. Serum creatinine ≤ 150 μmol\u002FL, and a calculated (Cockcroft-Gault) or estimated glomerular filtration rate (GFR) of ≥ 50 mL\u002Fmin measured within 2 weeks of enrolment.\n5. Haemoglobin concentration ≥ 90 g\u002FL; white blood cell (WBC) count ≥ 2 x 10\\^9\u002FL; platelets ≥ 100 x 10\\^9\u002FL measured within 2 weeks of enrolment.\n6. Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST)) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g\u002FL within 2 weeks of enrolment.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment.\n8. Provide written informed consent prior to enrolment.\n\nGroup A (Primary Therapy) Exclusion Criteria:\n\n1. Have previously received Lu-DOTA-TATE therapy.\n2. Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.\n3. Major surgery within 12 weeks of enrolment. Minor surgeries such as removal of superficial skin lesions, laser eye surgery, cataract surgery, laparoscopic procedures and other procedures that are minimally invasive are permitted at the Investigator's discretion.\n4. Liver embolization \\[transcatheter arterial embolization (TAE), TACE, or TARE\\] within 4 weeks of enrolment.\n5. Radioisotope therapy within 12 weeks of enrolment.\n6. Systemic therapy: mTOR inhibitors and tyrosine kinase inhibitors within 6 weeks of enrolment; chemotherapy and interferon within 8 weeks of enrolment.\n7. Change in long-acting somatostatin analogues, dosage, or dosage frequency within 12 weeks of enrolment unless changes are required to manage uncontrolled symptoms.\n8. Localized external beam irradiation with target lesion(s) in the radiation field. Other localized external beam therapy is permitted.\n9. Known brain metastases unless these metastases have been treated and stabilized (confirmed by CT) for ≥ 4 months prior to enrolment\n10. Uncontrolled diabetes mellitus defined as random glucose ≥ 2X the upper limit of normal (or HbA1c \\> 10%, if results available) within 12 weeks of enrolment.\n11. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).\n12. Pregnancy.\n13. Breast feeding.\n14. Prior radiation therapy to more than 25% of the bone marrow.\n15. If, in the opinion of the investigator, other treatments are considered more appropriate than the investigational therapy, based on patient and disease characteristics.\n16. Known allergy to somatostatin analogues or any components of the study medication.\n\nGroup B (Maintenance Therapy) Exclusion Criteria:\n\n1. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence or co-existing malignancies).\n2. Pregnancy.\n3. Breast feeding.\n4. Known allergy to somatostatin analogues or any components of the study medication.","14 Years","90 Years",{"count":306,"type":20},500,[23],"Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy with Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and has been widely used by research groups in Europe. A brand of Lu-DOTA-TATE (Lutathera(R)) is approved for the treatment of gastroenteropancreatic NETs in Europe, the U.S., and more recently in Canada. While Lutathera(R) is approved in Canada, it is not publicly funded in Alberta. Lu-DOTA-TATE has been used at the Cross Cancer Institute to treat more than 300 patients with NETs since August, 2010. Our Lu-DOTA-TATE treatment was initially given under Health Canada's Special Access Programme (SAP), with each individual treatment requiring separate approval. In 2014, Health Canada requested we conduct a clinical trial with Lu-DOTA-TATE instead.\n\nThe purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients with somatostatin receptor positive tumours; 2) assess the safety of Lu-DOTA-TATE; 3) assess the effect of Lu-DOTA-TATE on Quality of Life and survival.",[310],"Carcinoma, Neuroendocrine",[312],"177lutetium-DOTA(O)Tyr3)octreotate","2025-08-05",{"date":315,"type":36},"2025-08-08",{"date":317,"type":36},"2014-04-29",{"date":319,"type":20},"2042-12",{"name":42,"class":43},{"id":322,"slug":4,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":21,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":44},"100498814","NCT05775146","SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases","Phase II Single Arm Feasibility Trial to Evaluate Stereotactic Ablative Radiation of Metastases for the Management of Colorectal Cancer With Synchronous Oligo-metastases in Liver","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG (Eastern Cooperative Oncology Group) 0-2\n* Able to provide written informed consent\n* 1-5 Liver lesions with max size of ≤5cm for a single lesion and restricted to one lobe of liver; deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent\n* Liver lesion identified within 3 months of diagnosis of primary and deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent\n* Plan for resection of primary with curative intent\n* Patients with liver metastases and potentially resectable\u002Fablatable lung mets can be included.\n* Colon cancer patients who have undergone upfront resection of primary colonic lesion can be included\n* Able and willing to comply with the terms of the protocol including health-related quality of life (HRQoL) questionnaires\n* Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n* Females must not be breastfeeding\n* Male patients should agree to not donate sperm during the study\n\nExclusion Criteria:\n\n* Extra-hepatic metastases (except potentially resectable lung mets)\n* Not a suitable candidate for liver resection surgery\n* Not a suitable candidate for SBRT\n* Past history of cancer within 5 years (except basal cell carcinoma)\n* Patients who have undergone previous surgery or ablation for liver lesions\n* Planned simultaneous resection of primary and liver metastases\n* Pregnancy\n* Patients with Child-Pugh C and documented cirrhosis",{"count":328,"type":20},24,[23],"The purpose of this study is to prospectively evaluate the feasibility of SBRT for the management of synchronous oligo metastatic liver metastases from colorectal cancers.",[332,333],"Colorectal Cancer","Liver Metastasis Colon Cancer","2025-06-24",{"date":336,"type":36},"2025-06-27",{"date":338,"type":36},"2024-06-18",{"date":340,"type":20},"2028-06-30",{"name":42,"class":43},{"id":343,"slug":4,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":44},"100490257","NCT05663775","Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab\u002FNivolumab (Ipi\u002FNivo)","Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab\u002FNivolumab","IMPACT 1","Inclusion Criteria:\n\n1. Patients must be 18 years of age or older.\n2. Patients with histologically confirmed, unresectable stage III or IV malignant melanoma.\n3. Patients must be capable of providing consent to enrolment and treatment.\n4. Patients with a performance status of ECOG 0-224 will be eligible for enrolment (see appendix16.1).\n5. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n6. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   -Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n7. Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 30 days after the last dose of study drug.\n8. Male patients should agree to not donate sperm during the study and for a period of at least 30 days after last dose of study drug\n9. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n\n   * The following adequate organ function laboratory values must be met:\n\nHematological:\n\n* Absolute neutrophil count (ANC) \\>1.5 x109\u002FL\n* Platelet count \\>100 x109\u002FL\n* Hemoglobin \\>9 g\u002FdL (may have been transfused)\n\nRenal:\n\no Estimated creatinine clearance ≥ 30 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method)\n\nHepatic:\n\n* Total serum bilirubin \\\u003C2x ULN\n* AST and ALT \\\u003C2.5x ULN (or ≤ 5 x ULN for subjects with documented metastatic disease to the liver)\n\nExclusion Criteria:\n\n1. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n2. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n3. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5 Grade ≥ 3).\n4. Other severe acute or chronic medical conditions or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",{"count":350,"type":20},20,[23],"The study team's principal interest is to address the question, \"Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi\u002Fnivo?\"",[57,354,355,356],"Diarrhea","Advanced Melanoma","Advanced Rectal Carcinoma",{"date":336,"type":36},{"date":359,"type":36},"2024-08-20",{"date":361,"type":20},"2027-08",{"name":42,"class":43},{"id":364,"slug":4,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":21,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":44},"100473911","NCT05451043","Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)","A Study to Evaluate the Efficacy of Propranolol in Boosting Immunotherapy in Hepatocellular Carcinoma, Cholangiocarcinoma and Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n1. Patients must be 18 years of age or older.\n2. Body Weight \\>30kg\n3. Life expectancy of at least 12 weeks\n4. Patients must have a diagnosis of histologically documented advanced pancreatic adenocarcinoma, hepatocellular carcinoma, or BTC not amenable to curative intent local therapy or surgery. For the histologies there must only one histology type present ie not mixed cholangiocarcinoma\u002FHCC. For the HCC cohort if tissue biopsy if histological diagnosis is not possible, diagnosis can be made clinically by American Association for the study of liver diseases (AASLD) criteria in cirrhotic patients.\n5. Radiation therapy (palliative or curative) must have been completed at least 4 weeks prior to first study treatment and patients must have toxicities recovered to grade 1 or less.\n6. Patients must be capable of providing consent to enrolment and treatment.\n7. Patients with a performance status of ECOG 0-2(15) will be eligible for enrolment (see Appendix 1).\n8. Measurable disease must be present according to RECIST criteria V1.1(16) (see Appendix 3).\n9. Women of child-bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 50 years in the absence of other biological or physiological causes.\n10. Patients (men and women) of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n11. Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 90 days after the last dose of durvalumab monotherapy or 180 days after the last does of durvalumab + tremelimumab combination therapy.\n12. Male patients should agree to not donate sperm during the study and for a period of at least 6 months after last dose of study drug.\n13. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n14. The following adequate organ function laboratory values must be met:\n\nHematological:\n\n• Absolute neutrophil count (ANC) \\>1.5 x109\u002FL\n\n* For the Hepatocellular cohort Platelet count \\>\u002F 1.0 x109\u002FL is adequate • Platelet count \\>100 x109\u002FL\n* For the Hepatocellular cohort Platelet count \\>\u002F 65 x109\u002FL is adequate • Hemoglobin \\>9 g\u002FdL (may have been transfused)\n\nRenal:\n\n• Estimated creatinine clearance ≥ 45 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method)\n\nHepatic:\n\n* Total serum bilirubin \\\u003C1.5x ULN\n\n  o For the HCC cohort bilirubin ≤ 2 x ULN\n* AST and ALT \\\u003C2.5x ULN (or ≤ 5 x ULN for patients with documented metastatic disease to the liver)\n\nExclusion Criteria:\n\n1. Patients who have received prior palliative systemic treatment for their advanced cancer.\n2. History of pneumonitis requiring treatment with steroids.\n3. History of active interstitial lung disease.\n4. For HCC patients they must have a Child Pugh status of A.\n5. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n6. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n7. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) \\\u003C\\\u003Cfor durvalumab monotherapy and durvalumab + tremelimumab combination studies this criterion can be removed. For durvalumab ±tremelimumab in combination with an agent with pro-arrhythmic potential or where effect of the combination on QT is not known if this criterion should be retained.\n8. History of another malignancy or a concurrent malignancy;\n\n   • Exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ. As well patients with a resected malignancy that did not require systemic therapy post-surgery are allowed.\n9. Active brain metastases or leptomeningeal disease.\n\n   • Patients with treated brain metastases that have been treated, are off steroids and anticonvulsants and have imaging documenting stability of brain metastases for 6 weeks post treatment will be eligible for enrolment.\n10. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n11. Prior organ transplantation including allogeneic stem-cell transplantation.\n12. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n13. Active infection requiring systemic therapy or Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients known positive for HIV.\n14. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5.0 Grade ≥ 3).\n15. Other severe acute or chronic medical conditions including inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n16. Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 grade \\> 1); however, alopecia, sensory neuropathy ≤ grade 2, or other toxicities ≤ grade 2 not constituting a safety risk based on investigator's judgment are acceptable.\n17. Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.\n18. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy.\n19. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n20. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n21. Prior randomisation or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n22. Asthma requiring corticosteroid inhalers and having been admitted within the last year for an asthma exacerbation",{"count":370,"type":20},62,[23],"A single-arm, interventional study combining Immunotherapy and propranolol with\u002Fwithout chemotherapy and propranolol\n\n1. Pancreatic Cancer Durvalumab will be administered once every 4 weeks, in combination with gemcitabine + nab-paclitaxel (day 1\u002F8\u002F15) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.\n2. HCC Durvalumab will be administered once every 4 weeks in combination with continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.\n3. Biliary Tract Cancer (BTC, Cholangiocarcinoma of the gallbladder or bile ducts) Durvalumab will be administered once every 3 weeks, in combination with cisplatin + gemcitabine (day 1\u002F8) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.",[374,375,376,377],"Pancreatic Cancer","Hepatocellular Cancer","Biliary Tract Cancer","Cholangiocarcinoma",{"date":379,"type":36},"2025-06-26",{"date":381,"type":36},"2023-07-05",{"date":383,"type":20},"2029-10-01",{"name":42,"class":43},{"id":386,"slug":4,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":97,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":44},"100421232","NCT04765098","Tamoxifen Versus Etoposide After First Recurrence in GBM Patients","A Randomized Controlled Trial of Tamoxifen Versus Etoposide for Patients With First Recurrence of Glioblastoma Multiforme","Inclusion Criteria:\n\n1. Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.\n2. Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.\n3. Not received radiotherapy within the three months before the diagnosis of progression.\n4. Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema.\n5. ECOG performance 0-2 (Appendix 2).\n6. Age from 18-65 years.\n7. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.\n8. Patients of childbearing \u002F reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n9. Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:\n\n   * ANC ≥ 1.5 x 109\u002FL\n   * Platelets ≥ 100 x 109\u002FL\n   * Serum creatinine ≤ 1.5 times ULN\n   * Total serum bilirubin ≤ 1.5 times ULN\n   * ALT \\\u003C 3 times ULN\n   * AST \\\u003C 3 times ULN\n   * Alkaline phosphatase \\\u003C 3 times ULN\n10. Patient must understand and sign an informed consent prior to study registration.\n\nExclusion Criteria:\n\n1. History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.\n2. Uncontrolled hypertension (systolic blood pressure \\>150 mm Hg or diastolic blood pressure \\>100 mm Hg).\n3. Any arterial or venous thrombosis up to 6 months before registration.\n4. Evidence of recent hemorrhage on brain MRI.\n5. Substantial cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (\\> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.",{"count":392,"type":20},60,[23],"The investigator propose a single-center randomized phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.",[103],{"date":379,"type":36},{"date":398,"type":36},"2022-01-28",{"date":400,"type":20},"2027-07",{"name":42,"class":43},{"id":403,"slug":4,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":44},"100381130","NCT04242589","Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions","A Phase II Randomized Trial of Combined Radiotherapy and Vertebroplasty to Improve the Quality of Life of Patients With Painful Metastatic Localized Spinal Lesions","Inclusion Criteria:\n\n1. Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf\n2. Patients must be 18 years of age or older\n3. Spinal vertebral metastases confirmed by CT, MRI or bone scan.\n4. Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and \u002For lumbar spine (not cervical).\n5. Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures\n6. Life expectancy \\> 6 months. Life expectancy will be evaluated by the study investigator both clinically and by using Linden model. Patient should be in the group B or C of the Linden model.\n7. Patients with an ECOG score 0-2 or Karnofsky performance status of ≥ 60% will be eligible for enrolment (see appendix 1).\n8. No prior EBRT to the target +\u002F-1 vertebral body level\n9. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause\n10. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard) .\n11. Females must not breastfeed during study treatment.\n12. Male patients should agree to not donate sperm during study treatment.\n13. Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration\n\nExclusion Criteria\n\n1. Patient cannot provide consent\n2. Prior radiotherapy to the target +\u002F-1 vertebral body level\n3. Life expectancy \\\u003C 6 months (assessed both clinically and using Linden model)\n4. Karnofsky performance status of \\\u003C 60%\n5. Primary bone tumors\n6. Plasmacytoma\n7. Communicated fracture\n8. Associated Impending cord compression or spinal cord compression\n9. Epidural involvement",{"count":409,"type":20},64,[23],"Since patients with spinal metastases are living longer, durable palliation with long-term tumor control are becoming increasingly important.\n\nEBRT results in durable local control of bone metastasis. However, about 25 % of patients with spinal metastases only achieved complete pain relief following EBRT for a median duration of less than 4 months. This could be partly due to spinal instability. In addition, almost half of the patients who receive EBRT will subsequently develop VCFs . Hence, RT does not stabilize the spine secondary to VCFs and is not effective in preventing imminent VCFs. Vertebroplasty has rapidly reduced pain and improved function in patients with VCFs. However, vertebroplasty does not provide local tumor control similar to EBRT.\n\nIt is theorized that combining vertebroplasty with EBRT will stabilize the spine, relieve the pain, prevent imminent VCFs and minimize or avoid the need for opioids. It is hypothesized that combining a spine stabilization procedure such as vertebroplasty with RT will be the most effective management for patients with spinal metastases than RT alone for patients with spinal metastases. Combined vertebroplasty and radiotherapy is not a standard treatment option at present. This study is designed to quantify the advantage of adding vertebroplasty to radiotherapy for patients with spinal metastases. If the study is proven to be significant, it could become the standard of care for patients with spinal metastases.",[413],"Spinal Metastases",[415,416,28],"Vertebroplasty","Vertebral Compression Fracture",{"date":379,"type":36},{"date":419,"type":36},"2021-03-03",{"date":421,"type":20},"2027-11-01",{"name":42,"class":43},{"id":424,"slug":4,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":21,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":4},"100520535","NCT06057831","PET\u002FMRI in Rectal Cancer","18FDG-PET\u002FMRI Imaging in Predicting Pathological Response to Total Neo-adjuvant Therapy in Rectal Cancer","Inclusion Criteria:\n\n1. Patients with histologically proven adenocarcinoma of the rectum.\n2. Clinical stage 2-3 rectal adenocarcinoma, cT3\u002F4N0\u002FM0 or Tx N1-2\u002FM0, within 16 cm from anal verge (lesion below the sacral promontory).\n3. Patients deemed suitable to undergo TNT followed by surgical resection.\n4. Male or female ≥ 18 years of age.\n5. ECOG\u002FZubrod status 0-2.\n6. Able and willing to follow instructions and comply with the protocol.\n7. Provide written informed consent prior to participation in the study.\n8. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening if there is concern about pregnancy. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal.\n9. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, concerned about pregnancy are not eligible for the study.\n10. Females must not be breastfeeding (during treatment and at least 6 months from the last dose).\n11. Male patients should agree that not donate sperm during the study (during treatment and at least 6 months from the last dose).\n12. Patients of childbearing\u002Freproductive potential should use highly effective birth control methods if indicated, as defined by the investigator, up to the period of finishing adjuvant chemotherapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n\nNote: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n\nExclusion Criteria:\n\n1. Patient receiving short course radiotherapy alone for rectal cancer.\n2. Patient receiving standard TNT.\n3. Patients with metastatic disease.\n4. Prior pelvic radiotherapy or chemotherapy.\n5. Patients in whom MRI is contra-indicated as per prevailing institutional guidelines (e.g. pacemakers, aneurysm clips, cochlear implant, implanted cardiac defibrillator).\n6. Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years.\n7. Inability to lay in supine position for approximately one hour.\n8. Nursing or pregnant females.\n9. Age \\\u003C18 years.\n10. Previous and concurrent, experimental, chemotherapy, or radiotherapy treatment for primary rectal carcinoma.\n11. Patients with malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal (GI) function.\n12. Patients with a known history of documented upper GI bleeding or upper GI ulcerative disease.\n13. Patients who have experienced untreated and\u002For uncontrolled cardiovascular conditions and\u002For have symptomatic cardiac dysfunction.\n14. Known current alcohol abuse.\n15. Patients with symptomatic inflammatory bowel disease.\n16. Patients with uncontrolled hypothyroidism.\n17. Patients with chronic liver disease.\n18. Patients known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.\n19. Any contra-indications for intravenous contrast.\n20. History of anaphylactic reaction to medications or drug allergy.",{"count":198,"type":20},[23],"The purpose of this study is to see which participants have a better treatment response using PET\u002FMRI imaging to study the removed tumor, after they have received a total neoadjuvant therapy (TNT). The treatment choice of long course chemo-radiotherapy treatment will be determined by institutional policy.\n\nThe researchers will also be looking at whether this study could significantly improve the future management and quality of life of rectal cancer patients.",[433],"Rectal Cancer","2025-06-16",{"date":436,"type":36},"2025-06-18",{"date":251,"type":20},{"date":439,"type":20},"2030-12",{"name":42,"class":43},{"id":442,"slug":4,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":21,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":44},"100389728","NCT04354649","Immune-Mediated Pathophysiology And Clinical Triage Program","A Study to Evaluate the Efficacy and Safety Hydroxychloroquine in Immune Related Arthritis or Arthralgias","IMPACT 2","Inclusion Criteria:\n\n1. Patients must be 18 years of age, or older;\n2. Patients must be capable of providing consent to enrolment and treatment.\n3. Patients with a performance status of ECOG 0-2 will be eligible for enrolment (see appendix A).\n4. Patients with histologically confirmed cancer receiving anti-PD1 or anti-PDL1 monoclonal antibody ICI therapy, either alone or in combination with anti-CTLA4 monoclonal antibody ICI therapy who develop CTCAEv5.0 grade ≥2 arthritis or arthralgia that has developed on, or after, ICI therapy and is felt to be treatment related (irAA).\n5. Adequate hepatic and renal function defined by the following laboratory parameters:\n\n   * AST and ALT and alkaline phosphatase ≤ 2.5x ULN,\n   * Total bilirubin ≤ 1.5x ULN,\n   * Serum creatinine ≤ upper limit of institutional normal OR calculated creatinine clearance of ≥ 60 mL\u002Fmin using the Cockcroft-Gault formula.\n6. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n7. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, during the study treatment period and for a period of 3 months after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. These may include: hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation. Double-barrier methods may be acceptable in circumstances when highly effective methods cannot be implemented (e.g. male condom with diaphragm, male condom with cervical cap). Note: Contraceptive requirements for the oncology regiments will apply, if they are more stringent than those for this trial. Abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n8. Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 3 months after the last dose of study drug.\n9. Male patients should agree to not donate sperm during the study and for a period of at least 3 months after last dose of study drug.\n10. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion Criteria:\n\n1. History of inflammatory arthritis, including, but not limited to: Rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, Ankylosing spondylitis or other chronic inflammatory arthritis. Note: Patients with a known history of stable osteoarthritis will not be excluded.\n2. Patients with an indication for systemic immunosuppressive medications or corticosteroids. Patients with CTCAEv5.0 grade ≥2 irAE's other than irIAA (ie. colitis, pneumonitis, rash, etc) are not eligible for trial, with the exception of endocrinopathies that are being treated with hormone replacement alone and not systemic immunosuppressive medications or corticosteroids.\n3. Patients weighing \\\u003C 40 kg.\n4. Patients with G6PD deficiency, porphyria or psoriasis.\n5. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n6. Prolonged corrected QT interval or concurrent medications that prolong QT interval.\n7. Diagnosis of immunodeficiency.\n8. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n9. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAEv5.0 Grade ≥ 3).\n10. Other severe acute or chronic medical conditions including inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",{"count":449,"type":20},46,[23],"Many people develop joint pain, stiffness and swelling due to their cancer treatment that targets the immune system. The severity of symptoms ranges from mild to debilitating and sometimes requires delaying or stopping cancer treatment.\n\nThe usual plan is to discontinue cancer treatment and give relatively high doses of a medication called prednisone (a steroid, which is an anti-inflammatory medication which may suppress the immune system) with a gradual lowering of the dose over several weeks. While this can be effective, prednisone can cause a number of side effects, and it is not known if this is the best or safest treatment.\n\nHydroxychloroquine is a medication that is often used to treat inflammatory joint pain, such as rheumatoid arthritis, has relatively few side effects when compared to prednisone, and may be effective at treating this condition.\n\nThe purpose of this study is to find out whether it is better to receive hydroxychloroquine and prednisone, or prednisone alone for joint pain. To do this, some participants will get hydroxychloroquine and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable.\n\nThis is a double-blinded study, which means that neither participants nor the study doctor or study staff will know which group participants are allocated. After 12 weeks of study treatment, the blind will be opened and participants will be informed which treatment was given.",[453,454],"Arthritis","Arthralgia",{"date":436,"type":36},{"date":457,"type":36},"2021-09-16",{"date":459,"type":20},"2029-07",{"name":42,"class":43},{"id":462,"slug":4,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":21,"phases":469,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":44},"100471023","NCT05413473","Northern Alberta Linac-MR Image-Guided Radiotherapy (Northern LIGHTs-2)","Northern Alberta Linac-MR Image-Guided Human Clinical Trials - 2","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Patients deemed fit to undergo external beam radiation therapy by their attending radiation oncologist\n* Accessible for follow-up\n\nExclusion Criteria:\n\n* Patients with contraindications for MRI\n* Patients who are unable to lie flat and still for the duration of the expected scan acquisition and treatment\n* Patients who are unable to provide informed consent\n* Patients with clinically significant inferior treatment plans compared to standard CT based external beam plans. For example, plans that generate hot spots of \\> 110% or other unacceptable treatment plans that would not otherwise arise with standard CT based external beam plans.\n* Pregnancy",{"count":468,"type":20},99,[470,23],"PHASE1","Cancers are often treated with external beam radiotherapy. Current radiotherapy treatments are performed using computed tomography (also known as CT) scans which may not always clearly identify the cancer. In some instances, magnetic resonance imaging (MRI) may be able to better identify cancers. Therefore, efforts are currently underway to use the MRI scans to improve radiotherapy treatments or eventually even use radiotherapy equipment that only uses MRI scans to guide treatments. This new technology that will only use MRI scans to guide treatments is called the Linac-MR (linear accelerator with an MRI). This new Linac-MR is a unique innovation at the Cross Cancer Institute, with theoretical advantages over other Linac-MR machines that are being tested elsewhere in the world. This feasibility study is being done as a first step in clinical development of the Linac-MR, as this new technology has to be tested to see if it is acceptable to both doctors and participants. The purpose of this Phase I\u002FII study is (1) to verify treatment completion as intended and scheduled the oncology team, and (2) to evaluate treatment effects, including any expected or unexpected radiation side effects and cancer response to radiation. This study will allow the researchers at the Cross Cancer Institute to develop this technology further by conducting additional studies to take advantage of MRI scanning on tumor tracking during radiation treatments.",[473],"Cancer","2025-06-11",{"date":476,"type":36},"2025-06-15",{"date":478,"type":36},"2023-02-08",{"date":480,"type":20},"2030-01",{"name":42,"class":43},{"id":483,"slug":4,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":21,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":44},"100435611","NCT04952480","Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer","Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer (DARTS): A Prospective Phase II Trial Evaluating Local Control of Adaptive Dose-escalated Radiotherapy","DARTS","Inclusion Criteria:\n\n* Minimum 18 years of age\n* Biopsy proven, newly diagnosed, untreated SCLC\n* Completed standard of care staging investigations including: CT chest\u002Fabdomen\u002Fpelvis, bone scan and\u002For or PET-CT scan, CT head or MRI brain, or chest X-ray\n* Eligible for platinum doublet chemotherapy\n* Eligible for thoracic radiotherapy, which can also include ipsilateral supraclavicular lymph node disease\n* Capable of providing written, informed consent prior to participation in the study. Patient's legally authorized representative (LAR) may sign on behalf of the patient.\n* Able and willing to comply with protocol rules and follow-up regimen\n* Performance status of ECOG 0-2\n* Pulmonary function tests showing FEV-1 \\>1.0L and DLCO \\> 50% predicted\n* Radiation-targetable intrathoracic disease\n\nExclusion Criteria:\n\n* No intrathoracic disease seen to target with radiation\n* Thoracic disease is contiguous to extra-thoracic sites, beyond ipsilateral supraclavicular lymph nodes\n* Mixed histology disease\n* Active serious infection requiring therapy\n* Brain metastasis that has not been symptomatically stable on dexamethasone\n* 4 or more sites of extrathoracic disease, even if 2 or more of these are present in the same organ system\n* Previous CNS or thoracic radiotherapy\n* Previous chemotherapy\n* Ineligibility for platinum doublet chemotherapy\n* Life expectancy of less than 3 months\n* Prior thoracic surgery\n* History of another primary malignancy other than cutaneous basal cell carcinoma unless disease-free for at least 5 years\n* Pregnant or breast-feeding\n* In LS-SCLC, patients that are not eligible for concurrent chemoradiotherapy\n* In ES-SCLC, patients that are not eligible for concurrent chemoradiotherapy under the experimental arm\n* CT contrast allergy or kidney disease with irreversibly low creatinine clearance inadequate for IV contrast administration (for the purposes of high quality contrast enhanced CT chest and abdomen for follow-up imaging)\n* Lack of intrathoracic disease or intrathoracic disease spread not feasible to treat with adaptive radiotherapy\n* Participant in development and conduct of the research study",{"count":5,"type":20},[23],"The purpose of this study is to find out what effects of using adaptive radiotherapy to deliver chest radiation has on the ability to control lung cancer and side effects.",[493],"Small Cell Lung Cancer",[495,496],"Small cell lung cancer","(Dose-escalated) Adaptive radiotherapy","2025-06-10",{"date":499,"type":36},"2025-06-12",{"date":501,"type":36},"2022-06-13",{"date":503,"type":20},"2025-11-01",{"name":42,"class":43},{"id":506,"slug":4,"hasResults":11,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":50,"minAge":303,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":21,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":44},"100296966","NCT03145857","A Study to Evaluate a New Way to Identify\u002FDiagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use","A Phase I\u002FII Study of Gallium-68 HA-DOTATATE ([68]Ga-HA-DOTATATE) in Patients With Known or Suspected Somatostatin Receptor Positive Tumours","Inclusion Criteria:\n\n1. Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma. A standard CT obtained within 6 months of enrolment is required. A standard MRI obtained within 6 months of enrolment is optional. Additional supporting evidence obtained within 12 months of enrolment may include: other standard imaging (In-111 octreotide (Octreoscan), \\[18\\]F-FDG PET, or \\[18\\]F-FDOPA PET); histopathology from surgery or biopsy; elevated biochemical markers (including Chromogranin A, 5-HIAA, insulin, vasoactive intestinal peptide (VIP), glucagon, gastrin, metanephrines, and\u002For others, as clinically indicated); and\u002For persistent carcinoid-like symptomology highly suspicious for the presence of NET even in absence of pathologic imaging findings by anatomic criteria;\n2. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 3 within 2 weeks of enrolment;\n3. At least 14 years of age;\n4. Able and willing to follow instructions and comply with the protocol;\n5. Ability to provide written informed consent prior to participation in the study.\n\nExclusion Criteria:\n\n1. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);\n2. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);\n3. Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation;\n4. Weight exceeding the PET\u002FCT or PET\u002FMR scanner limit;\n5. Pregnancy;\n6. Allergic reaction to DOTATATE or somatostatin analogues.",{"count":512,"type":20},1534,[470,23],"A \\[68\\]Ga-HA-DOTATATE PET\u002FCT or PET\u002FMRI scan is a nuclear medicine test used to create pictures of the whole body that will show where somatostatin receptors are found, including on tumours. Somatostatin receptors are found on most neuroendocrine tumours (NETs), and some other types of tumours. Currently at the Cross Cancer Institute, most patients with suspected somatostatin positive tumours (e.g. NETs) have an In-111 Octreotide (Octreoscan™) scan. A scientific study has shown that a scan with a similar product (\\[68\\]Ga-DOTATATE) is more accurate than an Octreoscan™. This study will look at \\[68\\]Ga-HA-DOTATATE, a product virtually identical to \\[68\\]Ga-DOTATATE.\n\nThe purpose of this study is to: 1) demonstrate the safety of \\[68\\]Ga-HA-DOTATATE; and 2) confirm that \\[68\\]Ga-HA-DOTATATE PET\u002FCT or PET\u002FMRI is effective at diagnosing somatostatin positive tumours.",[516],"Neuroendocrine Tumors",[518,519,520],"Gallium-68","Positron Emission Tomography","68Ga-HA-DOTATATE","2025-05-12",{"date":523,"type":36},"2025-05-14",{"date":525,"type":36},"2020-03-05",{"date":527,"type":20},"2046-08",{"name":42,"class":43},{"id":530,"slug":4,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":21,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":44},"100390055","NCT04358913","MR Imaging Study Using the Northern Alberta Linac-MR (Northern LIGHTs - 1)","Northern Alberta Linac-MR Image-Guided Human Clinical Trials - 1","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Patients deemed fit to undergo high dose external beam radiation therapy by their attending radiation oncologist\n\nExclusion Criteria:\n\n* Patients with contraindications for MRI\n* Patients who are unable to lie flat and still for the duration of the expected scan acquisition\n* Patients who are unable to provide informed consent",{"count":241,"type":20},[78],"Cancers are often treated with external beam radiotherapy. Current radiotherapy treatments are performed using computed tomography (also known as CT) scans which may not always clearly identify the cancer. In some instances, magnetic resonance imaging (MRI) may be able to better identify cancers. Therefore, efforts are currently underway to use the MRI scans to improve radiotherapy treatments or eventually even use radiotherapy equipment that only uses MRI scans to guide treatments. This new technology that will only use MRI scans to guide treatments is called the Linac-MR (linear accelerator with an MRI). The purpose of this pilot phase of the study is to test whether the Alberta linac-MR P3 system at the Cross Cancer Institute can acquire high quality MR images safely. It will allow the researchers to develop the best collection of MR images possible with this new machine, in order to allow them to visualize tumors for future patients that are treated on this machine.",[473],"2025-05-09",{"date":523,"type":36},{"date":542,"type":36},"2021-08-23",{"date":544,"type":20},"2029-01",{"name":42,"class":43},""]