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RECRUITING
NCT07292298
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

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.

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