Phase 2 Rectal Cancer Brachytherapy for Organ Preservation

This study is for people with rectal adenocarcinoma (a type of rectal cancer) that hasn't completely gone away after standard chemotherapy and radiation. Instead of surgery, this trial tests if an additional treatment called High Rare Dose Rectal Brachytherapy Boost (a type of internal radiation using Iridium-192) can help you avoid surgery. This brachytherapy is given in three weekly treatments. The main goal is to see if this treatment can lead to a complete response, meaning you wouldn't need surgery to remove the rectum. To join, you must be 18-100 years old, have a good performance status (ECOG 0-3), and have MMR-proficient low-mid rectal adenocarcinoma. The study aims to enroll 44 participants.

Study design
This is a Phase 2, single-arm study, meaning all 44 participants will receive the High Rare Dose Rectal Brachytherapy Boost. The study is interventional.
What's involved
You would have an additional MRI pelvis and sigmoidoscopy with marker placement. Then, you would receive three outpatient brachytherapy treatments on a weekly basis.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study, organ preservation, will be measured at 2 years following study treatment.

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NCT07292298

Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Colorado, Denver
~44 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:High Rare Dose Rectal Brachytherapy Boost

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Organ preservation (no surgical requirement) of the rectum associated with complete clinical response
Measured over 2 years following study treatment
Rectal Adenocarcinoma
Rectal Cancer
3 sites across 3 states
Colorado1
New York1
Oregon1
  • David Binder · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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  • Organ preservation (no surgical requirement) of the rectum associated with complete clinical response2 years following study treatment

    As evaluated by standard of care sigmoidoscopy and MRI