RecruitingPhase 2NCT07292298

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

Enrollment

44 participants

Start Date

Nov 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether brachytherapy (internal radiation therapy placed directly inside or near the tumor) can effectively treat remaining rectal cancer after total neoadjuvant therapy (intensive pre-surgery chemotherapy and radiation) in patients whose cancer has not fully disappeared and who would otherwise need extensive surgery. **You may be eligible if...** - You are an adult (18–100 years old) with low-to-mid rectal cancer - You completed total neoadjuvant therapy but still have some remaining tumor (not a complete response) - Without brachytherapy, your surgical options would require an APR (abdominoperineal resection, which creates a permanent colostomy) or a very low bowel reconnection - You are in reasonably good health (ECOG 0–3) **You may NOT be eligible if...** - Your cancer has a mismatch repair deficiency (dMMR) - Your tumor has completely responded to prior treatment - You have other conditions that prevent brachytherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHigh 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

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NCT07292298


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