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

Recruiting Phase 2 Interventional Study
Rectal Adenocarcinoma Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
University of Colorado, Denver · Other
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About This Trial
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) recta…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Adults (18-100 years old) 4. ECOG 0-3 5. Patients with MMR-proficient low-mid rectal adenocarcinoma cT1-4 N0-2 M0 who unde…
Contacts

Radiation Therapy Group

303-724-8822

RTClinicalResearch@olucdenver.onmicrosoft.com

CONTACT

Alex Fonder

alex.fonder@cuanschutz.edu

CONTACT