[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"astrocytoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:astrocytoma":489},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,46,89,170,192,218,245,266,291,315,341,368,392,413,442,463],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100542535",false,"NCT06344130","Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","* INCLUSION CRITERIA:\n* Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.\n* Age \\>= 18.\n* KPS \\>= 70%.\n* Previous tumor irradiation to curative-intent doses.\n* Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000\u002FmicroL\n  * Platelets \\>= 100,000\u002FmicroL\n* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Recent systemic therapy prior to the initiation of the study therapy as follows:\n\n  * Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.\n  * Temozolomide within 2 weeks.\n  * Cytotoxic chemotherapy within 3 weeks.\n  * Any investigational agents within 2 weeks.\n* Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.\n* Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.\n* Requiring radiation therapy within 12 months prior to the initiation of study therapy.\n* History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.\n* Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.\n* Participants with known or suspected radiation sensitivity syndromes.\n* Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.","ALL","18 Years","120 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Background:\n\nGlioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.\n\nObjective:\n\nTo find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.\n\nEligibility:\n\nPeople aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.\n\nParticipants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.\n\nParticipants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.\n\nParticipants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.\n\nParticipants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.",[26,27,28],"Astrocytoma","Glioma","Recurrent Glioblastoma",[30,31,32],"Radiotherapy","Hypofractionation","Re-irradiation","RECRUITING","2026-06-24",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":37},"2024-10-01",{"date":41,"type":20},"2027-12-31",{"name":43,"class":44},"National Cancer Institute (NCI)","NIH",1,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":10,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100528530","NCT06161974","Study of Olutasidenib and Temozolomide in HGG","Phase 2 Study of Olutasidenib With Temozolomide as Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations","Criteria TarGeT-D study strata definitions\n\n* Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3.\n* Stratum B: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4.\n* Stratum C: Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG.\n\nInclusion Criteria:\n\n1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:\n\n   1.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis:\n   * Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible. All patients must have tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR.\n   * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, and histopathology consistent with diffuse WHO Grade 2-4 glioma.\n   * All other HGG must be WHO Grade 3 or 4.\n\n   1.3) Disease status: There are no disease status requirements for enrollment\n   * Measurable disease is not required. Patients without measurable disease are eligible.\n   * Primary spinal tumor: Patients with a primary spinal HGG are eligible.\n   * Patient must not have metastatic disease.\n2. Inclusion criteria for assignment to TarGeT-D, for all strata:\n\n2.1 Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here:\n\n* R132H, R132C, R132S, R132G or R132L.\n* Patients whose tumors harbor other alterations in addition to IDH1 mutation will potentially be eligible following consensus recommendation by the international multidisciplinary molecular screening committee.\n* Patients with IDH2 mutations are not eligible.\n* Patients with oligodendroglioma, IDH-mutant and 1p\u002F19q-codeleted are not eligible.\n\n2.2 Weight: Patients must weigh ≥35 Kg (77 lbs) at the time of enrollment on TarGeT-D.\n\n2.3 Performance Level: Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n2.4 Prior Therapy 2.4.1 Surgery, radiation, and\u002For dexamethasone are permissible. Temozolomide administered concurrently with radiotherapy is permissible. Prior administration of bevacizumab is allowed, given at least 42-day washout period is completed prior to beginning treatment on TarGeT-D. No other prior anticancer therapy for HGG will be allowed.\n\n2.4.2 Radiation therapy requirements: RT, delivered via photon or proton beam, must have been administered at a standard dose including 54 Gy in 30 fractions for DIPG, 55-59.4 Gy in 30-33 fractions for other HGG or 45-54 Gy for primary spinal cord HGG. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Study Chair to confirm eligibility prior to study enrollment.\n\n2.4.3 Timing between diagnosis and start of RT: Patients must have started RT \\\u003C 42 calendar days of initial diagnosis defined as the date of diagnostic biopsy or resection; if a patient underwent two upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.\n\n* Patients in pre-maintenance phase must enroll and start treatment no later than 21 calendar days post-completion of RT.\n* Patients not in pre-maintenance phase must enroll and start treatment no later than 35 calendar days post-completion of RT.\n\n2.5 Organ Function Requirements 2.5.1 Adequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm3.\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Hemoglobin \\> 8 g\u002FdL (may be transfused). 2.5.2 Adequate Renal Function Defined as\n* Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 OR\n* Maximum serum creatinine based on age\u002Fgender as follows: 10 to \\\u003C 13 yrs=1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 yrs=1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n2.5.3 Adequate Liver Function Defined as:\n\n* Total bilirubin must be ≤ 1.5 × institutional ULN.\n* AST(SGOT)\u002FALT(SGPT) \\\u003C 3 × institutional ULN.\n* Alkaline Phosphatase \\\u003C 3 × institutional ULN. 2.5.4 Adequate Neurologic Function Defined as:\n\n  * Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not a strong inducer or inhibitor of CYP3A4\u002F5.\n  * Patients must be able to swallow oral medications to be eligible for study enrollment.\n\n2.6. Informed consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria:\n\n1. Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown potential risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy.\n\n   A highly effective contraception method is defined as one that results in a low failure rate (\\\u003C1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:\n   * Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.\n   * Progesterone-only hormonal contraception associated with inhibition of ovulation.\n   * Intra Uterine Device (IUD).\n   * Intra uterine hormone releasing system.\n   * Bilateral tubal occlusion.\n   * Vasectomized partner.\n   * Sexual abstinence (avoiding heterosexual intercourse).\n   * The following contraceptive measures are NOT considered effective:\n\n     * Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation.\n     * Male or female condom with or without spermicide.\n     * Cap, diaphragm, or sponge with spermicide.\n2. Using the following types of concomitant medications:\n\n   * Corticosteroids: Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.\n   * Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.\n   * Anti-cancer Agents: Concurrent anti-cancer agents are not allowed with the exception of temozolomide given concurrently with RT and as protocol-instructed post RT maintenance therapy after enrollment on TarGeT-D.\n   * Anticonvulsants: Patients who are receiving enzyme inducing anticonvulsants that are strong inducers of CYP3A4\u002F5 are not eligible.\n   * Strong CYP3A4\u002F5 inducers: Patients who are receiving strong inducers of CYP3A4\u002F5 are not eligible. Strong inducers of CYP3A4\u002F5 should be avoided from 14 days prior to or 5 half-lives (whichever is longer) enrollment to the end of the study.\n   * Patients who are receiving medications known to prolong QTc interval are not eligible\n   * Selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft) should be used with caution but are not contraindicated.\n3. Other Criteria\n\n   * Infection: Patients who have an uncontrolled infection are not eligible.\n   * Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n   * Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.\n   * Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history.\n   * Patients with prior or ongoing clinically significant illness, medical or psychiatric condition, that, in the investigator's opinion, could affect the safety of the participant, or could impair the assessment of study results are not eligible.\n   * Patients with any prior solid organ transplant are not eligible.\n   * Patients with secondary\u002Fradiation-related HGG are not eligible.\n   * Patients with metastatic\u002Fdisseminated HGG who have received CSI are not eligible.","12 Years","39 Years",{"count":55,"type":20},60,[57],"PHASE2","The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.\n\nThe main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.",[60,26,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"High Grade Glioma","Astrocytoma, Grade III","Astrocytoma, Grade IV","Diffuse Intrinsic Pontine Glioma","WHO Grade III Glioma","WHO Grade IV Glioma","Metastatic Brain Tumor","Diffuse Midline Glioma, H3 K27M-Mutant","Thalamus Tumor","Spinal Tumor","IDH1 Mutation","IDH1 R132","IDH1 R132C","IDH1 R132H","IDH1 R132S","IDH1 R132G","IDH1 R132L","Oligodendroglioma","2026-06-10",{"date":80,"type":37},"2026-06-12",{"date":82,"type":37},"2025-02-01",{"date":84,"type":20},"2035-06",{"name":86,"class":87},"Rigel Pharmaceuticals","INDUSTRY",20,{"id":90,"slug":4,"hasResults":10,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":10,"sex":15,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":134,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":169},"100355699","NCT03911388","HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 36 months and \\\u003C 22 years\n* Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid\u002Frhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and\u002For chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible.\n* Lesion must be ≥ 1.0 cm ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking\n* Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study.\n* Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea)\n* Investigational\u002FBiologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to entering this study (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥ 7 days). For viral therapy, patients must have received viral therapy ≥ 3 months prior to study entry and have recovered from all acute toxicities potentially related to the agent.\n* Monoclonal antibodies: The patient must have received last dose ≥ 21 days prior.\n* Radiation: Patients must have received their last fraction of craniospinal radiation (\\>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to study entry.\n* Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to study entry.\n* Normal hematological, renal and liver function (absolute neutrophil count \\> 1000\u002Fmm3, platelets \\> 100,000\u002Fmm3, prothrombin time (PT) or partial thromboplastin time (PTT) \\\u003C 1.3 x control, creatinine within normal institutional limits OR creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal, total bilirubin \\\u003C 1.5 mg\u002Fdl, transaminases \\\u003C 3 times above the upper limits of the institutional norm)\n* Patients \\\u003C 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60\n* Patient life expectancy must be at least 8 weeks\n* Written informed consent in accordance with institutional and FDA guidelines must be obtained from patient or legal guardian\n\nExclusion Criteria:\n\n* Any treatment outside the allowable guidelines outlined in section 5.1.\n* Diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain\n* Acute infection, granulocytopenia or medical condition precluding surgery\n* Pregnant or lactating females\n* Diagnosis of encephalitis or CNS infection \\\u003C 3 months prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis\n* Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment\n* Required steroid increase within 1 week prior to G207 inoculation or patients requiring \\>2 mg of dexamethasone daily\n* Known HIV seropositivity\n* Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).\n* Other current malignancy\n* Concurrent anticancer or investigational drug","3 Years","21 Years",{"count":98,"type":20},24,[23],"This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested.\n\nFunding Source- FDA OOPD",[102,103,104,105,26,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133],"Neoplasms, Brain","Glioblastoma Multiforme","Glioblastoma of Cerebellum","Neoplasms","Astrocytoma, Cerebellar","Neuroectodermal Tumors","Neuroectodermal Tumors, Primitive","Cerebellar PNET, Childhood","Cerebellar Neoplasms","Cerebellar Neoplasms, Primary","Cerebellar Neoplasm, Malignant","Cerebellar Neoplasm Malignant Primary","Neoplasm Metastases","Neoplasm Malignant","Neoplasms, Neuroepithelial","Neoplasms, Germ Cell and Embryonal","Neoplasms by Histologic Type","Neoplasms, Glandular and Epithelial","Neoplasms, Nerve Tissue","Central Nervous System Neoplasms, Primary","Central Nervous System Neoplasms, Malignant","Nervous System Neoplasms","Neoplasms by Site","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Medulloblastoma Recurrent","HSV","Virus","Pediatric Brain Tumor","Nervous System Cancer","Primitive Neuroectodermal Tumor (PNET) of Cerebellum",[135,27,103,136,137,138,77,139,140,141,142,143,144,145,146,147,105,148,149,150,151,152,153,154,155,130,129,156,157,158],"Brain Tumor, Recurrent","Gliosarcoma","Medulloblastoma","Anaplastic Astrocytoma","Rhabdoid Tumor","Ependymoma","Germ Cell Tumor","Choroid Plexus Carcinoma","Cerebral Primitive Neuroectodermal Tumor","Giant Cell Glioblastoma","Atypical teratoid\u002Frhabdoid tumor","Secondary Malignant Cerebellar Tumor","Embryonal Tumor","Oncolytic Virus Therapy","Virotherapy, Oncolytic","Immunotherapy","Central Nervous System Agents","Antineoplastic Agents","Pediatric","Pediatrics","Oncolytic","Herpes Virus","G207","Oncolytic Herpes Virus","2026-05-13",{"date":161,"type":37},"2026-05-15",{"date":163,"type":37},"2019-09-12",{"date":165,"type":20},"2027-09-01",{"name":167,"class":168},"M.D. Anderson Cancer Center","OTHER",3,{"id":171,"slug":4,"hasResults":10,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":45},"100636067","NCT07560865","First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma","Inclusion Criteria:\n\n* Histologically confirmed WHO Grade 4 astrocytoma from archival tissue. IDH mutation status and MGMT promoter methylation status will not limit candidacy but needs to be known.\n* Evidence of first or second cancer recurrence\u002F progression by magnetic resonance imaging (MRI) for which a gross tumor resection (GTR) is feasible as determined by the primary investigator in concordance with the study-affiliated neurosurgeon.\n* Previous completed SOC antitumor treatment including surgery, radiation therapy, and temozolomide +\u002F- Optune\u002F Tumor Treatment Fields (TTF).\n* No concurrent alternative curative therapy, including use of TTF.\n* Able to undergo standard MRI scans with contrast agent throughout the course of the study.\n* ≥ 18 years and ≤ 75 years of age at the time of consent.\n* Karnofsky performance status ≥70.\n* Must be completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function at the time of enrollment.\n* Adequate organ function within 14 days of study treatment start as defined in Section 4.1.9 of the protocol.\n* Participants of childbearing potential (POCBP) or with partners of childbearing potential must use a highly effective form of contraception from the time of the screening visit until at least 3 months after the dose of FT536.\n* Must agree to and sign the consent for the companion Long-Term Follow-Up study (CPRC# 2021LS077).\n* Voluntary written consent prior to the performance of any research related procedures.\n* Agree to stay in the Twin Cities metropolitan area (i.e. within a 45-minute drive of the UMN) from the time of biopsy through hospital discharge following completion of the planned craniotomy.\n\nExclusion Criteria:\n\n* Clinically significant increased intracranial pressure (e.g., impending herniation or requirement for immediate palliative treatment) or uncontrolled seizures or any other situation requiring urgent neurosurgical intervention.\n* History of myelodysplastic syndrome (MDS)\u002F acute myeloid leukemia (AML) or with features suggestive of MDS\u002F AML.\n* Radiographic evidence of leptomeningeal disease.\n* Received prior treatment with bevacizumab or any other cellular therapy available on or off a clinical trial.\n* Non-malignant CNS disease such as CNS vasculitis or neurodegenerative disease.\n* Prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy.\n* Any known condition that requires systemic immunosuppressive therapy - inhaled and topical steroids are permitted.\n* Pregnant or breastfeeding. Menstruating POCBP must have a negative pregnancy test within 14 days before the planned biopsy. Patient must agree to use highly effective method of birth control from the time of the screening visit until at least 3 months after the dose of FT536.\n* Known seropositive for HIV or known Hepatitis B or C infection with detectable viral load by PCR.\n* Prior history of malignancy within 5 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of \\\u003C0.01 ng\u002FmL tested within 28 days of trial enrollment.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pec","75 Years",{"count":177,"type":20},9,[23],"This is a single center, first-in cancer-type phase I clinical trial of FT536 for adult patients with recurrent WHO Grade 4 astrocytoma, irrespective of IDH-mutational status, for which a standard of care repeat craniotomy for gross tumor resection at time of first or second recurrence is achievable. Per this treatment schema, FT536 will be administered once intratumorally",[26,181,182],"Glioblastoma","Progressive Disease","2026-04-24",{"date":185,"type":37},"2026-05-01",{"date":187,"type":37},"2026-04-23",{"date":189,"type":20},"2029-06-01",{"name":191,"class":168},"Masonic Cancer Center, University of Minnesota",{"id":193,"slug":4,"hasResults":10,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100625063","NCT07417761","Tuvusertib in Astrocytoma With ATRX Mutation","Efficacy of Tuvusertib in Recurrent IDH Mutant Astrocytoma With ATRX Mutation, a Phase II Prospective Trial.","TUVASTRAT","Inclusion Criteria:\n\n1. Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.\n2. Patients, males and females, ≥ 18 years of age at the time of signing the informed consent.\n3. Patients with Karnofsky performance status (KPS) index \\> 60% (Appendix 5).\n4. Diagnosis of Grade 2-4 astrocytoma, IDH-mutated according to the 2021 WHO classification.\n5. Patients must have confirmed ATRX mutation (IHC or NGS sequencing) and p53 mutation (NGS sequencing). Evaluation of CDKN2A also is required by FISH or NGS.\n6. Patients must have progressive disease and evaluable disease according to RANO 2.0 criteria. All patients should have MRI contrast enhancement disease.\n7. Patients must have undergone previous standard treatment with radiotherapy and chemotherapy (procarbazine, lomustine and vincristine \\[PCV\\] or temozolomide \\[TMZ\\]).\n8. Stable corticosteroid doses during the 2 weeks previous to the first dose of tuvusertib, maximum dose of dexamethasone 4 mg\u002Fday or equivalent.\n9. Adequate hematologic, hepatic and renal function as follows:\n\n   1. Platelet count ≥ 100,000\u002Fmm3,\n   2. Hemoglobin ≥ 9.0 g\u002FdL,\n   3. Absolute neutrophil count ≥ 1,500\u002FμL with no growth factor treatment within the last 14 days,\n   4. Total bilirubin level ≤ 1.5 × upper limit of normal (ULN) (if Gilbert's Syndrome may have total bilirubin \\> 1.5 × ULN),\n   5. Aspartate aminotransferase (AST) level ≤ 3 × ULN, and an alanine aminotransferase (ALT) level ≤ 3 × ULN.\n   6. Serum creatinine ≤ 1.5 × ULN. If serum creatinine is \\> 1.5 × ULN, creatinine clearance needs to be ≥ 50 mL\u002Fmin, as estimated by Cockcroft-Gault\n10. Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies.\n11. Patients able to take oral medications.\n12. Willingness and ability of patients to comply with the protocol for the duration of the study including undergoing treatment as well as availability for scheduled visits and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Patients with radiographic recurrence without contrast enhancement by MRI.\n2. Leptomeningeal dissemination and\u002For extracranial metastases.\n3. Patients who received more than 1 previous systemic line of treatment for astrocytoma.\n4. Patients who received previous treatment with bevacizumab.\n5. Persistence of AEs related to any prior treatments that have not recovered to Grade ≤ 1 unless AEs are clinically nonsignificant (e.g. alopecia) and\u002For stable on supportive therapy in the opinion of the Investigator.\n6. No prior ATR inhibitor and\u002For CHK1 inhibitor.\n7. Concurrent treatment with a non permitted drug\u002Fintervention:\n\n   1. Prohibited concomitant medication, as listed in Section 7.8.\n   2. Anticancer treatment within 30 days or 5 half-lives, whichever is shorter, prior to Day 1 of study intervention (6 weeks for nitrosoureas or mitomycin C).\n   3. Prior palliative radiotherapy to metastatic lesion(s) is permitted provided it was completed ≥ 12 weeks prior to study intervention administration and participants have recovered from all related radiotherapy toxicities to Grade ≤ 1.\n   4. Another investigational drug within 30 days or 5 half-lives, whichever is shorter, prior to start of tuvusertib administration.\n   5. Increasing dose of corticoids.\n   6. Received hematopoietic growth factor (e.g., granulocyte colony-stimulating factor, erythropoietin) within 14 days prior to the first dose of tuvusertib.\n8. Significant cardiac disease:\n\n   1. Unstable angina, myocardial infarction, congestive heart failure ≥ stage II) or a coronary revascularization procedure within 180 days of study entry.\n   2. Calculated QTc average (using the Fridericia correction calculation) of \\> 450 msec for males and \\> 470 msec for females.\n   3. Uncontrolled hypertension.\n9. Active and\u002For uncontrolled infection. The following exceptions apply:\n\n   1. Participants with HIV infection are eligible if they are on effective antiretroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction\n   2. Participants with evidence of chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels \\\u003C ULN, and provided there is no expected drug-drug interaction\n   3. Participants with a history of HCV infection are eligible if they have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load, and if they have ALT, AST, and total bilirubin levels \\\u003C ULN.\n\n11\\. Treatment with live or live attenuated vaccine within 30 days of dosing.\n\n12\\. Known hypersensitivity to the components of tuvusertib.\n\n13\\. Major surgery (as deemed by the Investigator) for any reason, except diagnostic biopsy, within 4 weeks of the study intervention and\u002For if the patient has not fully recovered from the surgery within 4 weeks of the study intervention.",{"count":200,"type":20},56,[57],"The TUVASTRAT study is a phase 2, non-randomized, two.cohort, CRS clinical trial of tuvusertib in patients with first recurrence of IDH1\u002F2-mutated, ATRX-mutated and p53-mutated astrocytoma (Grade 2-4 from WHO classification). The mutational status of IDH (required for diagnosis) is also required. CDKN2A and ATRX will be also determined locally as per standard of care.\n\nAll enrolled patients should have received first-line chemotherapy and have reported a contrast enhanced PD. Eligible patients are enrolled in two cohorts depending on their eligibility to undergo rescue surgery:\n\n* Cohort A: First recurrence of IDH1\u002F2-mutated, ATRX-mutated astrocytoma NOT eligible for rescue surgery.\n* Cohort B: First recurrence of IDH1\u002F2-mutated, ATRX-mutated astrocytoma candidates to rescue surgery.\n\nThe primary hypothesis is that treatment with tuvusertib, an ATR inhibitor, will improve the efficacy outcomes and increase the 6-months PFS rate from 45% reported by the standard therapies up to 65% in patients with recurrent IDH-mutated astrocytomas with ATRX mutation.\n\nClinic visits will occur every 3 weeks ±3 days. Tumor assessments by MRI according to RANO 2.0 criteria will be performed at baseline, and every 12 weeks +\u002F-2 weeks (Q12W) until PD, patient withdrawal, start of new treatment line or death. This schedule must be maintained regardless of any delays in dosing. After the first suspect of progression, we recommend a second MRI at 4-8 weeks to confirm the progression, except if there is clinical progression. The MRI imaging will be assessed by PI and central radiologists.\n\nThe trial includes the assessment of safety (AEs, comorbidities) throughout the study period at every visit, the collection of health-related patient reported outcomes through validated questionnaires at baseline, coincident with the tumor assessments and at the safety visit. Neurologic \u002F neurocognitive status will be assessed through validated tests administered by the physicians. Additionally, ATRX, IDH, P53 and CDK2A mutations will be centrally reviewed in tumor biopsies or archival tumor tissue obtained as close as possible to the baseline. PKs will be determined in sparse peripheral blood samples during the treatment phase.\n\nThe study includes a data safety monitoring committee (DSMC) to regularly review safety and efficacy. The DSMC will review efficacy and safety at least yearly and more frequently if deemed necessary.",[26],[205,26,206,207],"Tuvusertib","IDH mutated","ATRX mutated","2026-04-01",{"date":210,"type":37},"2026-04-02",{"date":212,"type":37},"2025-12-19",{"date":214,"type":20},"2028-09",{"name":216,"class":168},"Grupo Español de Investigación en Neurooncología",10,{"id":219,"slug":4,"hasResults":10,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":4},"100626710","NCT07439172","Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.","A Multi-Centered Evaluation of Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma (HGG): An Approach to Drug Screening That Requires Confirmation","PRC","Inclusion Criteria:\n\n1. Pathologic diagnosis of high-grade glioma\n2. Residual measurable post-operative contrast enhancing tumor\n3. Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.)\n4. Ability to provide informed consent\n5. Willingness to comply with all study procedures and availability for the duration of the study\n6. Male or female, aged 18-80.\n7. Karnofsky Performance Status ³70%.\n8. Patients must have the following organ and marrow functions:\n\n   Absolute neutrophil count ≥1,500\u002FµL Platelets ≥100,000\u002FµL Hemoglobin ≥ 9 g\u002FdL Total bilirubin £ 1.5 × institutional upper limit of normal (ULN), (except for patients with known Gilbert's syndrome who must have normal direct bilirubin) AST (SGOT)\u002FALT (SGPT) £ 2.5 × ULN Creatinine £ 1.5 × ULN OR Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73m2 APTT\u002FPTT ≤ 1.5 × ULN Sodium ≥ the institutional lower limit of normal\n9. Ability to take oral medication and be willing to adhere to the pre-radiation temozolomide regimen\n10. For females of reproductive potential: use of highly effective contraception for at least 1 week prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of pr-radiation temozolomide administration\n11. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner\n12. Patients must have measurable disease as defined by RANO criteria.\n\nExclusion Criteria:\n\n1. Patients receiving any other investigational agents are ineligible.\n2. Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection.\n3. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible.\n4. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, are ineligible.\n5. Pregnant women are excluded from this study because TMZ has potential for teratogenic or abortifacients effects. Breastfeeding should be discontinued if the mother is treated with TMZ.","80 Years",{"count":227,"type":20},70,[57],"Better treatments are needed for high-grade gliomas (HGG), and new ways of treating this disease should be tested. The investigators want to see if giving medicine before radiation works well. After radiation, MRI scans can be harder to understand because radiation changes how the brain looks on the scan. If new medicines are given before radiation, the scans are easier to read.\n\nFirst, the investigators need to find out if giving chemotherapy early works using a drug we already know can treat gliomas. The investigators will start with temozolomide, which is the only chemotherapy approved by the FDA for HGG. If this approach is successful, the investigators can then test new drugs using this screening method.",[231,181,26,77],"High Grade Gliomas",[27,181,60,233,26,77,234],"Brain Tumor","Temozolomide","NOT_YET_RECRUITING","2026-02-23",{"date":238,"type":37},"2026-02-27",{"date":240,"type":20},"2026-03",{"date":242,"type":20},"2029-09",{"name":244,"class":168},"The Cooper Health System",{"id":246,"slug":4,"hasResults":10,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":21,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":45},"100465767","NCT05345002","All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma","A Phase 2 Trial of All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma","Inclusion Criteria:\n\n1. Prior histopathologically proven diagnosis of astrocytoma (grade 2-4) or oligodendroglioma (grade 2-3) according to the World Health Organization (WHO) 2021 Classification System that is progressive or recurrent following at least one prior alkylating chemotherapy regimen (i.e., temozolomide and\u002For lomustine), +\u002F- radiation therapy\n2. Patient's tumor must have a known mutation in IDH1 or IDH2. IDH1\u002F2 mutation status must be confirmed by DNA sequencing and could have been performed in any CLIA\u002FCAP-certified laboratory. IDH1\u002F2 mutational testing could have been performed on patient's tumor either at initial diagnosis or on a subsequent recurrent tumor.\n3. Safety Run-In and Phase 2 (Arm A and Arm B) patients:\n\n   * All Safety Run-In and Phase 2 patients: patients with any contrast-enhancing tumor must have measurable disease per RANO criteria (defined by at least 1cmx1cm of contrast-enhancing tumor). Patients with exclusively non-enhancing tumors must have least a 25% increase in bi-dimensional product of FLAIR signal abnormality (measurable disease) compared to the patient's best MRI scan (smallest bi-dimensional product of FLAIR signal abnormality) obtained following completion of the patient's most recent line of therapy\n   * Safety Run-In: Must have failed temozolomide OR another alkylator (e.g. lomustine, procarbazine, carmustine). May have failed an unlimited number of prior systemic regimens, +\u002F- prior radiotherapy.\n   * Arm A: Must have failed temozolomide AND another alkylator (e.g. lomustine, procarbazine, carmustine). May have failed an unlimited number of prior systemic regimens, +\u002F- prior radiotherapy.\n   * Arm B: Must have failed temozolomide OR another alkylator (maximum one prior chemotherapy regimen) +\u002F- prior radiotherapy, AND must have gone at least 12 months since last treatment (chemotherapy or radiotherapy).\n4. Surgical patients (Arm C and Arm D):\n\n   * Must have clinical indication for surgical resection of the suspected recurrent\u002Fprogressive tumor, as determined by patient's care providers; measurable disease is not required\n   * 5-aminolevulinic acid (5-ALA) is not allowed for intraoperative tumor visualization due to the photosensitizing agent interaction with ATRA\n   * Patient may have had an unlimited number of relapses and prior therapy regimens\n5. Patients must be able to undergo MRI of the brain with gadolinium. Patients must be maintained on a stable or decreased dose of corticosteroid regimen (no increase for 5 days) prior to this baseline MRI.\n6. Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\n\n   * 12 weeks from completion of radiation\n   * 6 weeks from a nitrosourea cytotoxic chemotherapy\n   * 3 weeks from a non-nitrosourea cytotoxic chemotherapy\n   * 4 weeks from any investigational (not Food and Drug Administration \\[FDA\\]-approved) agents, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter\n   * 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g. abemaciclib, olaparib, etc)\n7. If patient is on systemic corticosteroids to treat brain edema and\u002For brain edema-related symptoms, the dose must be 2mg of dexamethasone (or equivalent) daily or less for a minimum of 5 days prior to first dose of retifanlimab.\n8. Patients must be able to swallow oral medications\n9. Age 18 or older\n10. Karnofsky performance status greater than or equal to 60\n11. Life expectancy \\>3 months\n12. Adequate organ and marrow function:\n\n    * Total bilirubin \\\u003C1.5 x upper limit of normal (ULN) (except patients with suspected Gilbert's Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion)\n    * ALT and AST ≤ 2.5x ULN\n    * Calculated CrCl ≥ 30 ml\u002Fmin (glomerular filtration rate can also be used in place of CrCl)\n    * Absolute Neutrophil count ≥1,500\u002FuL\n    * Platelets ≥ 100,000\u002FuL\n    * Hemoglobin ≥ 9 g\u002FdL\n13. Reproductive Status\n\n    1. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to the start of study drug.\n    2. b) Women must agree to not breastfeed during the study or for 180 days after the last dose of study treatment\n    3. WOCBP must agree to use an adequate method to avoid pregnancy (as defined below) from the time of study screening through 180 days from last dose of study drug\n    4. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (as defined below) starting with the first dose of study drug through 180 days after the last dose of study\n    5. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, these WOCBP must still undergo pregnancy testing as described in this section.\n\n    At a minimum, participants of childbearing potential who are sexually active and their partners must agree to the use of a highly effective form of contraception (as defined below) throughout their participation beginning with the time of consent, during the study treatment, and for 180 days after last dose of study treatment(s).\n\n    HIGHLY EFFECTIVE METHODS OF CONTRACEPTION:\n    * Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) by WOCBP subject or male subject's WOCBP partner. Female partners of male subjects participating in the study may use hormone-based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug\n    * Nonhormonal IUDs\n    * Bilateral Tubal ligation\n    * Vasectomy\n    * Sexual Abstinence\n\n      * It is not necessary to use any other method of contraception when complete abstinence is elected.\n      * WOCBP participants who choose complete abstinence must continue to have pregnancy tests.\n      * Acceptable alternate methods of highly effective contraception must be discussed in the event that the WOCBP participants chooses to forego complete abstinence.\n14. Participant must, in the opinion of the Investigator, be able to comply with study procedures\n15. Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent (or have legally authorized representative sign on patient's behalf if patient physically unable to sign consent due to neurologic deficit)\n\nExclusion Criteria:\n\nAny of the following would exclude the subject from participation in the study:\n\n1. Contrast-enhancing tumor in brainstem or spinal cord (subjects do not need spinal MRI for screening, but known spinal cord tumor is exclusionary)\n2. Diffuse leptomeningeal disease\n3. Patients who have received bevacizumab within the last 3 months are ineligible\n4. Patients with clinically significant mass effect or midline shift (e.g., 1-2 cm of midline shift)\n5. Use of any immunosuppressive medication other than steroids, including but not limited to antimetabolites, calcineurin inhibitors, and\u002For anti-TNF agents within six months of start of study drug\n6. Prior diagnosis of immunodeficiency\n7. Prior solid organ or bone marrow transplantation\n8. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n\n   * Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n   * Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.\n   * Participants using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption) may participate.\n   * Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedications are permitted.\n\n   EXCEPTIONS: Patients with the following autoimmune diseases may participate: type I diabetes mellitus, hypothyroidism only requiring hormone replacement, Grave's disease that is previously treated with thyroidectomy or radioiodine, celiac disease with symptoms controlled with a gluten-free diet.\n9. Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.\n10. Immune related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).\n11. Known active hepatitis B virus (HBsAg reactive) or active hepatitis C virus (HCV RNA detectable by PCR)\n12. Human immunodeficiency virus (HIV)-positive patients on antiretroviral therapy\n13. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are excluded from this trial. Otherwise, patients with prior or concurrent malignancy are eligible.\n14. Any serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection that, in the opinion of the investigator, would put the subject at undue risk from the study treatment.\n15. Patients with uncontrolled or significant cardiovascular disease including, but not limited to, any of the following are ineligible:\n\n    * Myocardial infarction or uncontrolled angina within 90 days prior to consent\n    * History of clinically significant arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n    * History of cardiomyopathy, pericarditis, significant pericardial effusion, myocarditis, or New York Heart Association (NYHA) functional class III-IV congestive heart failure\n16. Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (e.g., antihistamines and corticosteroids)\n17. Known allergy or hypersensitivity to any component of retifanlimab or formulation components.\n18. Known allergy or hypersensitivity to all-trans retinoic acid (tretinoin), any of its components, or other retinoids\n19. Prisoners or subjects who are involuntarily incarcerated\n20. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness\n21. Pregnant women are excluded\n22. Has received a live vaccine within 28 days before the planned start of study treatment\n\n    Note: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n23. Participant must not be simultaneously enrolled in any interventional clinical trial",{"count":252,"type":20},55,[57],"This is a Phase II study of the combination of All-Trans Retinonic Acid (ATRA) and PD-1 inhibition (Retifanlimab) in patient with recurrent IDH-mutant glioma. The Sponsor-Investigator hypothesizes that the proposed regimen will be safe and stimulate a robust anti-tumor immune response.",[27,256,26,77],"IDH Mutation","2026-02-19",{"date":259,"type":37},"2026-02-20",{"date":261,"type":37},"2022-11-16",{"date":263,"type":20},"2028-06-01",{"name":265,"class":168},"Stephen Bagley, MD, MSCE",{"id":267,"slug":4,"hasResults":10,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":45},"100491797","NCT05683808","Venous Thromboembolism Prevention in Outpatients With Glioma","VTE-POG","Inclusion Criteria:\n\n* Histologic diagnosis of malignant glioma, World Health Organization (WHO) grade 4, including glioblastoma and astrocytoma, based on recent biopsy or resection.\n* Age 18 and old\n* Karnofsky performance status (KPS) 60-100\n* Acceptable labs, including platelets of greater than or equal to 100,000, glomerular filtration rate (GFR) greater than or equal to 25.\n* Ability to provide informed consent.\n* Planning for treatment with radiation and chemotherapy.\n\nExclusion Criteria:\n\n* Evidence of deep venous thrombosis (DVT), pulmonary embolism (PE), or cerebral vein thrombosis (CVT) within 6 months prior to enrollment on the study.\n* Pregnancy.\n* Significant bleeding risk including: history of symptomatic intracranial hemorrhage, active bleeding at time of study registration, clinically significant bleeding within 14 days of study registration, intracranial trauma in the past 6 months, including stroke or traumatic brain injury, major surgery or major procedure within 48 hours.\n* Allergy to apixaban or contraindication to prophylactic anticoagulation. Contraindications include patients who are currently on unfractionated heparin, low molecular weight heparin, heparin derivatives (examples: fondaparinux), or other direct oral anticoagulants (examples: dabigatran, edoxaban, rivaroxaban), who are either unable or unable to discontinue these agents in favor of the investigational drug. Apixaban is also contraindicated in patients who are on strong CYP3A4 inhibitor and P-glycoprotein inhibitors.\n* Indication for full anticoagulation (i.e. atrial fibrillation, mechanical valve, etc.).\n* Estimated life expectancy of \\\u003C3 months.",{"count":273,"type":20},40,[57],"This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.",[181,26,277],"Venous Thromboembolism",[279,181,26,280,281],"High grade glioma","Venous thromboembolism","Apixaban","2026-01-27",{"date":284,"type":37},"2026-01-30",{"date":286,"type":37},"2023-01-16",{"date":288,"type":20},"2027-06-30",{"name":290,"class":168},"University of Vermont Medical Center",{"id":292,"slug":4,"hasResults":10,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":45},"100492027","NCT05686798","Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.","Phase I Study of Replication-Competent Adenovirus-Mediated Double Suicide Gene Therapy With Stereotactic Radiosurgery in Patients With Recurrent or Progressive High Grade Astrocytomas","Inclusion Criteria:\n\n1. Subjects with radiologic evidence of intracranial recurrence or progression of a previously diagnosed high-grade astrocytoma.\n\n   To be eligible for this trial, the subjects must have:\n   * Histologically documented glioblastomas or anaplastic astrocytoma prior to the debulking surgery that is suspicious to have progressed on imaging. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiation while at least 4 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen and at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen.\n   * Patients must be ≥ 18 years of age, able to provide informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study.\n   * Must have recovered from toxicity (grade 2 or less) of prior therapy.\n   * Eligible for partial or total resection of the recurrent tumor\n   * No anticipated physical connection between post-resection tumor cavity and cerebral ventricle\n   * Karnofsky performance status (KPS) ≥ 60 at time of surgery\n   * No prior treatment of the tumor with gene or virus therapy, immunotherapy, brachytherapy, or implants of polymers containing chemotherapeutic agents (e.g. Gliadel Wafer)\n   * No immunosuppressive or immune disorder\n   * Baseline organ function testing intact\n   * Patients who are candidates for surgical debulking (re-resection) following recurrence of diseases based on multidisciplinary evaluation by neurosurgeons, radiation oncologists, neuro-radiologists, and neuro-oncologists.\n2. Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:\n\n   * Adequate renal function with creatinine clearance ≥ 50 mL\u002Fmin\u002Fm2\n   * Platelet count ≥ 100,000\u002FμL\n   * Absolute neutrophil count ≥ 1,000\u002FμL\n   * Hemoglobin \\> 10.0 g\u002FdL\n   * Bilirubin \\\u003C 1.5 mg\u002FdL; SGOT and SGPT \\\u003C 2.5 times upper limit of normal (ULN).\n3. Women of child-bearing potential will be required to practice birth control for the duration of the treatment and for at least 90 days after surgery with intratumor virus inoculation. Men must use barrier protection for the duration of treatment and for at least 90 days after surgery with intratumor virus inoculation treatment.\n\nExclusion Criteria:\n\n* Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required active treatment and caused oral temperature \\>38.5oC and\u002For clinically significant leukocytosis\n* Serum antibodies to human immunodeficiency virus (HIV)\n* Previous history of liver disease including autoimmune or viral hepatitis\n* Positive serologic test for Hepatitis B or C at baseline\n* Immunosuppressive therapy except for corticosteroid use\n* Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial\n* Impaired immunity or susceptibility to serious viral infections\n* Pregnant or lactating females\n* Allergy to any product used on the protocol\n* Patient is not able to undergo a brain MRI.\n* Patients who are not eligible for debulking surgery or resection of recurrent disease will be considered ineligible.",{"count":298,"type":20},18,[23],"The primary goal of this Phase I study is to determine the maximum tolerated dose of oncolytic adenovirus mediated double suicide-gene therapy in combination with fractionated stereotactic radiosurgery in patients with recurrent high-grade astrocytoma undergoing resection.",[302,26,303,233,27,304,181,103,305],"Malignant Glioma of Brain","Malignant Astrocytoma","Brain Cancer","GBM","2025-12-08",{"date":308,"type":37},"2025-12-16",{"date":310,"type":37},"2022-11-29",{"date":312,"type":20},"2027-12",{"name":314,"class":168},"Henry Ford Health System",{"id":316,"slug":4,"hasResults":10,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":323,"briefSummary":325,"conditions":326,"keywords":330,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":45},"100592104","NCT06989086","FearLess in NeuroOncology","FearLess in Neuro-Oncology","Inclusion Criteria:\n\nPatients:\n\n* Self-report a diagnosis of a primary malignant brain tumor (grade II-IV)\n* \\>2 weeks post-cranial resection or biopsy\n* Elevated Fear of Recurrence Distress Rating\n* Primarily English speaking\n* \\>\u002F= 18 years of age at the time of enrollment\n\nCaregivers:\n\n* nonprofessional caregiver to a patient with a primary malignant brain tumor (grade II-IV)\n* Elevated Fear of Recurrence Distress Rating\n* Primarily English speaking\n* \\>\u002F= 18 years of age at the time of enrollment\n\nExclusion Criteria:\n\nPatient \u002F Caregiver Exclusion:\n\n* Cognitive impairment that might prohibit active intervention engagement\n* Inability to understand and provide informed consent\n* Inability to attend virtual sessions due to unstable or no internet connection",{"count":322,"type":20},112,[324],"NA","The overarching goal of this project is to assess the feasibility, acceptability, and appropriateness of recruitment methods, target population, and a waitlist design to finalize the protocol of FearLess in primary malignant brain tumor patients and caregivers",[327,328,26,77,329],"Primary Malignant Brain Tumor","Glioblastoma (GBM)","Caregiver",[331],"brain tumor","2025-09-02",{"date":334,"type":37},"2025-09-09",{"date":336,"type":37},"2025-06-24",{"date":338,"type":20},"2028-12-31",{"name":340,"class":168},"Virginia Commonwealth University",{"id":342,"slug":4,"hasResults":10,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":351,"conditions":352,"keywords":359,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":366,"locationsCount":45},"100372929","NCT04135807","Implantable Microdevice In Primary Brain Tumors","A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors","Inclusion Criteria:\n\n* Patients must have operable supratentorial tumor presumed to be WHO grade II-IV glioma (Astrocytoma, Oligodendroglioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, or Glioblastoma) based on radiological evidence at MRI, where a gross total or partial surgical resection is intended.\n* Histological confirmation of WHO grade II-IV glioma at time of intraoperative frozen analysis (for newly diagnosed tumors). This is not necessary in cases where a histopathologic diagnosis is already available from prior surgeries\u002Fbiopsies.\n* Participants must be 18 years of age or older.\n* Karnofsky Performance Score ≥ 60 (Appendix C).\n* Participants must have normal organ and marrow function as defined below:\n\n  * Leukocytes ≥ 3,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelets ≥ 100,000\u002FmcL\n  * Total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional upper limit of normal\n  * Creatinine within normal institutional limits OR\n  * Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n* Participants must be evaluated by a neurosurgeon who will determine the feasibility of microdevice implantation based on clinical history, extent, and anatomical location of the tumor.\n* Because participants will be exposed to microdoses of therapeutic agents only in a localized setting and for a short period of time (2-4 hours), the risk of interaction with other drugs routinely assumed by participants is considered not applicable. Thus, participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes remain eligible.\n* The effects of the microdevice on the developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to have a negative serum pregnancy test within 48 hours prior to registration. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the microdevice or any agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because agents released by the microdevice have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents used in this study, breastfeeding should be discontinued if the mother is treated in the study for a total of 14 days after removal of the microdevice.\n* Tumor size \\\u003C 5 cm3.\n* Tumor located in deep brain structures (e.g. thalamus, brainstem).\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical procedures.\n* If there are significant risk factors (e.g. high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines, patients will be excluded from the trial.",{"count":348,"type":20},12,[350],"EARLY_PHASE1","This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors.\n\n* The device involved in this study is called a microdevice.\n* The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.",[353,354,355,26,356,357,358,181],"Grade II Glioma","Grade III Glioma","Grade IV Glioma","Oligodendroglioma of Brain","Anaplastic Astrocytoma of Brain","Anaplastic Oligodendroglioma",[353,354,355,26,356,357,181],"2025-07-18",{"date":362,"type":37},"2025-07-23",{"date":364,"type":37},"2020-03-03",{"date":263,"type":20},{"name":367,"class":168},"Oliver Jonas",{"id":369,"slug":4,"hasResults":10,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":391},"100506821","NCT05879367","Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","Inclusion Criteria:\n\n* Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A\u002FB intact) per WHO 2021 tumor classification.\n* Completed external beam radiation therapy per standard of care.\n* Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.\n* Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.\n* Willing to abstain from intercourse or use acceptable contraceptive methods.\n* If taking corticosteroids, must be on a stable or decreasing dose.\n\nExclusion Criteria:\n\n* Recent history of recurrent or metastatic cancer that could confound response assessments\n* Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).\n* Prior Optune treatment.\n* Active infection or serious intercurrent medical illness.\n* Poorly controlled seizures.\n* Significant cardiac disease within 6 months of enrollment.\n* Poorly controlled diabetes.\n* Use of another investigational agent within 30 days of enrollment.",{"count":375,"type":20},66,[23],"The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.",[379,181,103,380,305,26,381],"Glioblastoma, IDH-wildtype","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Astrocytoma, IDH-Mutant","2025-06-19",{"date":384,"type":37},"2025-06-25",{"date":386,"type":37},"2023-07-24",{"date":388,"type":20},"2026-06-30",{"name":390,"class":87},"Orbus Therapeutics, Inc.",8,{"id":393,"slug":4,"hasResults":10,"nctId":394,"briefTitle":395,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":21,"phases":400,"briefSummary":401,"conditions":402,"keywords":403,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":409,"leadSponsor":411,"locationsCount":45},"100577389","NCT06797661","Insights Into the Pathophysiology of Neurovascular Uncoupling in Patients with Brain Lesions.","NVUCVR","Inclusion Criteria:\n\n* patients in the study include prior imaging showing a potentially resectable intra-cerebral mass lesion. Patient has to be included before surgery, chemotherapy and radiation\n\nExclusion Criteria:\n\n* previous brain surgery\n* respiratory failure\n* Asthma\n* Claustrophobia\n* Previous adverse reaction to gadovist (contrast agent)\n* Pregnancy and Breath feeding\n* Diabetes (type I and II)","90 Years",{"count":273,"type":20},[324],"Neurovascular uncoupling (NVU) represents a major source of potential bias for the identification of eloquent brain regions through activation procedures in blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI).\n\nSame region shows proper pattern in glucose metabolism in victiny of brain lesions, investigated with positron emitted tomography with radiolabeled glucose (PET-FDG) This research project aims at investigating the mechanisms of NVU by using a multimodal noninvasive imaging approach in neurosurgical patients.",[181,27,26],[404],"Primary brain tumor","2025-02-17",{"date":407,"type":37},"2025-02-19",{"date":405,"type":37},{"date":410,"type":20},"2026-12-31",{"name":412,"class":168},"Erasme University Hospital",{"id":414,"slug":4,"hasResults":10,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":418,"targetDuration":420,"studyType":421,"phases":4,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":169},"100412277","NCT04648462","Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology","Inclusion Criteria:\n\n1. All brain tumors with a favorable prognosis (median survival \\> 10 year)\n2. Age ≥ 18 years\n3. ECOG performance status 0 - 1 \u002F Karnofsky performance status 80 - 100\n4. No - minimal neurocognitive impairment\n5. Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi)\n6. Informed consent\n\nExclusion Criteria:\n\n1. Not eligible for chemotherapy\n2. Eligible for stereotactic radiotherapy",{"count":419,"type":20},1500,"5 Years","OBSERVATIONAL","The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. In turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. The Netherlands has spearheaded the development of the model-based approach (MBA) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. In MBA, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (ΔDose), and (2) whether this dose difference translates into an expected clinical benefit in terms of NormalTissue Complication Probabilities (ΔNTCP). To translate ΔDose into ΔNTCP, NTCP-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. The Dutch Society for Radiotherapy and Oncology (NVRO) setup the selection criteria for proton therapy in 2015, taking into account toxicity and NTCP. However, NTCP-models can be affected by changes in the irradiation technique. Therefore, it is paramount to continuously update and validate these NTCP-models in subsequent patient cohorts treated with new techniques. In ProTRAIT, a Findable, Accessible, Interoperable and Reusable (FAIR)data infrastructure for both clinical and 3D image and 3D dose information has been developed and deployed for proton therapy in the Netherlands. It allows for a prospective, standardized, multi-centric data from all Dutch proton and a representative group of photon therapy patients.",[26,140,424,77,425,426,427,428,429,430,431,432],"Ganglioglioma","Optic Nerve Glioma","Meningioma","Nerve Sheath Neoplasms","Adenoma","Craniopharyngioma","Hemangiopericytoma","Germinoma","Neurilemmoma","2024-11-25",{"date":435,"type":37},"2024-11-26",{"date":437,"type":37},"2018-01-01",{"date":439,"type":20},"2035-01-01",{"name":441,"class":168},"Maastricht Radiation Oncology",{"id":443,"slug":4,"hasResults":10,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":175,"enrollmentInfo":448,"targetDuration":4,"studyType":421,"phases":4,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":45},"100480206","NCT05532969","Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma","Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma: a Longitudinal Study Based on Long-term Follow-up","Inclusion Criteria:\n\n* age ≥18 years\n* Karnofsky Performance Score ≥ 70 %\n* histologically confirmed, previously untreated glioma\n* receiving a standardized chemoradiotherapy regimen\n* no previous history of mental illness, drug abuse, or alcohol abuse\n* ability to communicate and read and write independently\n* willing and able to comply with the protocol as judged by the investigator's signed informed consent.\n\nExclusion Criteria:\n\n* Patients who have any other disease, either metabolic or psychological, or who have any evidence on clinical examination or special investigations (including laboratory findings) which give reasonable suspicion of a condition that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids ≥ 3 months before study entry for diseases other than glioblastoma, (dexamethasone use in the context of glioblastoma is allowed) severe, medically treated psychiatric disorder prior to the diagnosis of glioblastoma Participation in a study with investigational drugs.\n* pregnancy or breast-feeding\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurologic deficits that interfere with the planned walking tests, dementia, or confusional state.",{"count":55,"type":20},"It is a single-center, prospective, observational, non-randomized study of newly diagnosed diffuse astrocytoma patients conducted in a tertiary hospital. The investigators conduct an eight-year follow-up, including patients' psychological stress, immune biomarker changes, quality of life, and disease progression of patients towards secondary glioma after the first definite diagnosis. In the first year after diagnosis, patients are followed up four times at 1 month, 3 months, 6 months, and 12 months. After that, patients are followed up semiannually.\n\nThe study had two cohorts, a high-stress cohort and a low-stress cohort, which are grouped after initial recruitment. Both groups undergo total resection of tumors and received 3 months of standardized treatment with radiotherapy and chemotherapy. Neither participants nor doctors but the researcher can choose which group participants are in. No one knows if one study group is better or worse than the other.",[26],[26,452,453],"Psychological stress","progression","2022-09-25",{"date":456,"type":37},"2022-09-27",{"date":458,"type":20},"2022-12-20",{"date":460,"type":20},"2026-12-20",{"name":462,"class":168},"Henan Provincial People's Hospital",{"id":464,"slug":4,"hasResults":10,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":471,"briefSummary":473,"conditions":474,"keywords":476,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":45},"100182422","NCT01649830","Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma","Inclusion Criteria:\n\n* Age: 18 years to 60 years\n* Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or oligodendroastrocytoma\n* Karnofsky Performance Score ≥ 60\n* Adequate bone marrow, liver and renal function\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate the study\n* Known hypersensitivity or contraindication to temozolomide\n* Previous irradiation, prior radiosurgery or prior chemotherapy\n* Pregnant or lactating females\n* Malignant tumor other than brain tumor\n* Contraindicated for MRI examination\n* Unable to comply with the follow-up studies of this trial","60 Years",{"count":470,"type":20},290,[472],"PHASE3","Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative nature and frequent growth in eloquent area in brain often makes total resection impossible. Until now, no agreement has been achieved on the treatment of LGG without total resection. Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas. However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to be defined. In this randomized controlled trial, the investigators will test the hypothesis that radiotherapy with subsequent TMZ chemotherapy is superior to improve the progression-free survival of patients with residue LGG without significant impairment to quality of life compared to radiotherapy alone.",[26,77,475],"Oligodendroastrocytoma",[477,478,479],"low-grade glioma","radiotherapy","chemotherapy","2020-05-26",{"date":482,"type":37},"2020-05-28",{"date":484,"type":4},"2012-07",{"date":486,"type":20},"2026-08",{"name":488,"class":168},"Sun Yat-sen University",""]