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

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 sigmoidos

Trial Details

NCT ID
NCT07292298
Phase
PHASE2
Sponsor
University of Colorado, Denver
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • High Rare Dose Rectal Brachytherapy Boost
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Rochester, New York, United States|43.15478,-77.61556
  • Portland, Oregon, United States|45.52345,-122.67621

Key Eligibility Criteria

  • Provision to sign and date the consent form.
  • Stated willingness to comply with all study procedures and be available for the duration of the study.
  • Adults (18-100 years old)
  • Patients with MMR-proficient low-mid rectal adenocarcinoma cT1-4 N0-2 M0 who underwent total neoadjuvant therapy who have not achieved complete res…

For full eligibility, visit ClinicalTrials.gov.

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