Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
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.
Description
Rectal cancer patients with incomplete responses following standard of care chemotherapy and radiation are offered surgery as part of curative intent regimens. Similarly, patients with near-complete responses following initial therapy may require future salvage surgery given high local recurrence risk in the rectum. The goal of this study is to determine whether additional "internal" focal radiation delivered by rectal brachytherapy can provide a complete tumor response, such that patients can avoid surgical intervention. While rectal brachytherapy efficacy, technique, and safety has been demo…