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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- David Binder · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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What this trial measures
- 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