[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615414":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":74,"collaborators":76,"id":79,"slug":20,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":20,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":20,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HDR Rectal Brachytherapy Boost","EXPERIMENTAL","The intervention consists of a boost using Iridium-192 delivered via an intracavitary applicator in three weekly fractions totaling 21 Gy. The goal is to improve organ preservation rates and avoid surgical resection (APR or low LAR). Treatment planning includes MRI, endoscopic clip placement, and CT simulation prior to each fraction.",[13],"Radiation: High Rare Dose Rectal Brachytherapy Boost",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","High Rare Dose Rectal Brachytherapy Boost","HDR rectal brachytherapy boost using Iridium-192 delivered via an intracavitary applicator in three weekly fractions (total dose: 21 Gy) for patients with low-lying residual rectal adenocarcinoma following total neoadjuvant therapy.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"David Binder","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Radiation Therapy Group","CONTACT","303-724-8822","RTClinicalResearch@olucdenver.onmicrosoft.com",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Alex Fonder","alex.fonder@cuanschutz.edu",[35,53,64],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Colorado Cancer Center","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-104.83192,39.72943,{"lat":47,"lon":46},[50,51],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":52,"role":24,"phone":20,"phoneExt":20,"email":20},"David Binder, MD, PhD",{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":20},"University of Rochester Medical Center","NOT_YET_RECRUITING","Rochester","New York","14642",{"type":44,"coordinates":60},[61,62],-77.61556,43.15478,{"lat":62,"lon":61},{"facility":65,"status":55,"city":66,"state":67,"zip":68,"country":41,"countryCode":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":20},"Oregon Health and Sciences University","Portland","Oregon","97239",{"type":44,"coordinates":70},[71,72],-122.67621,45.52345,{"lat":72,"lon":71},{"type":75,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[77],{"name":78,"class":6},"Cancer League of Colorado","100615414",false,"NCT07292298","Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates","Inclusion Criteria:\n\n1. Provision to sign and date the consent form.\n2. Stated willingness to comply with all study procedures and be available for the duration of the study.\n3. Adults (18-100 years old)\n4. ECOG 0-3\n5. Patients with MMR-proficient low-mid rectal adenocarcinoma cT1-4 N0-2 M0 who underwent total neoadjuvant therapy who have not achieved complete response (i.e. incomplete or near-complete) in the rectal primary tumor such that surgical resection, if offered presently or in the future, would be an APR or low LAR per colorectal surgeon expert opinion and central review at University of Colorado rectal tumor board. Tumor restaging will be 4-16 weeks following completion of total neoadjuvant therapy, and no sooner than 8 weeks if patients received chemotherapy followed by chemoradiation\u002Fshort course radiation.\n6. Residual rectal disease must have its craniocaudal extent \\\u003C4 cm with thickness \\\u003C1.2 cm. Tumor must have \\\u003C50% circumferential involvement. Residual disease must be above the dentate line and not involving the anal canal.\n7. In patients with original cN1-2 disease, restaging CT and MRI after total neoadjuvant therapy must demonstrate at least near-complete response of the pelvic lymph nodes per NCCN criteria as evaluated by central review at University of Colorado rectal tumor board.\n8. Interval of time between completion of TNT and initiation of rectal brachytherapy must be between 4-16 weeks.\n9. Patients must be recovered from total neoadjuvant therapy and must not have significant rectal incontinence at time of screening.\n10. Received conventionally fractionated external beam chemoradiation between 45-56 Gy or short-course external beam radiation prescription of 25 Gy to rectal mucosa, in addition to systemic chemotherapy before or after radiation per National Comprehensive Cancer Network (NCCN) guidelines.\n11. Women of child-bearing potential must have a negative urine or serum pregnancy test within 14 days of HDR treatment.\n12. Men and women of reproductive potential who are sexually active must agree to follow instructions of contraception for the duration of the study and 6 months post-rectal brachytherapy completion.\n13. CBC at the time of screening must have platelets\\>50 10\\^9\u002FL, Hemoglobin\\>8 g\u002FdL and Absolute Neutrophil Count \\> 500 10\\^9\u002FL\n\nExclusion Criteria:\n\n1. History of ulcerative colitis or Crohn's disease.\n2. Pelvic radiotherapy given prior to rectal cancer external beam radiation.\n3. Prior colorectal surgery in which anastomotic site is at or near HDR brachytherapy target.\n\n   o Prior local excision is not an exclusion criterion.\n4. Uncontrolled intercurrent severe 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.\n5. Life expectancy \\\u003C3 years per provider discretion.\n6. Concurrent administration of any cytotoxic chemotherapy, immunotherapy, or other any targeted oncologic agent that would impact rectal cancer is not allowed during study protocol.\n7. If rectal cancer has been treated outside of standard total neoadjuvant therapy per NCCN guidelines, patients are ineligible for the trial. This includes if patients received external beam chemoradiation dose with prescription \\>56 Gy or short-course radiation to rectal mucosa prescription \\>30 Gy.\n8. Pregnant women.","ALL","18 Years","100 Years",{"count":88,"type":89},44,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Rectal cancer patients who do not achieve a complete response to standard of care chemotherapy and radiation often require surgical resection as part of curative intent therapy. This study will evaluate whether additional \"focal\" radiation delivered internally (rectal brachytherapy) can provide complete responses and thus spare the requirement for surgery.\n\nThe main questions are whether: 1) rectal brachytherapy is safe in this clinical treatment paradigm and if 2) rectal brachytherapy improves organ preservation (no need for surgery).\n\nThe trial involves an additional MRI pelvis and sigmoidoscopy with marker placement to define high-risk residual disease for radiation planning. Subsequently, 3 outpatient brachytherapy treatments are given on a weekly basis. If a patient achieves a complete response to brachytherapy, standard of care non-operative surveillance visits are conducted with study visits aligned during the first two years following brachytherapy.",[95,96],"Rectal Adenocarcinoma","Rectal Cancer",[98,99,100],"Locally Advanced Rectal Cancer","Non-metastatic Rectal Cancer","Rectal Neoplasms","2026-04-03",{"date":103,"type":104},"2026-04-06","ACTUAL",{"date":106,"type":89},"2026-11",{"date":108,"type":89},"2031-11",{"name":5,"class":6},3]