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Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
Sponsor: University of Colorado, Denver
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-11
Completion Date
2031-11
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (3)
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Rochester Medical Center
Rochester, New York, United States
Oregon Health and Sciences University
Portland, Oregon, United States