Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates (NCT07292298)
🩺 Plain-English Summary (8th-Grade Level)
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. The 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). The 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.
Who can join: Review the eligibility criteria below.
Location: University of Colorado Cancer Center — Aurora, Colorado
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
- High Rare Dose Rectal Brachytherapy Boost (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- University of Colorado Cancer Center — Aurora, Colorado
- University of Rochester Medical Center — Rochester, New York
- Oregon Health and Sciences University — Portland, Oregon
📞 Contact the Study Coordinator
Phone: (303) 724-8822
Email: RTClinicalResearch@olucdenver.onmicrosoft.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rectal Adenocarcinoma
- Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma — Tampa, Florida
- ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer — Portland, Oregon
- ctDNA-Informed Management of Early-Stage Rectal Cancer — Sacramento, California
- Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors — Hartford, Connecticut
- Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer — Houston, Texas
- Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer — Portland, Oregon
Explore by condition: All Rectal Adenocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.