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NCT07292298 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
A Phase 2 study of Rectal Cancer and Rectal Adenocarcinoma, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 3
- Study locations
NCT07292298 is a Phase 2 study of Rectal Cancer and Rectal Adenocarcinoma that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 44 participants, below the 3,166-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT07292298, a Phase 2 study of Rectal Cancer and Rectal Adenocarcinoma, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- RADIATION High Rare Dose Rectal Brachytherapy Boost
Study Locations (3)
Colorado
- University of Colorado Cancer Center - Aurora
New York
- University of Rochester Medical Center - Rochester
Oregon
- Oregon Health and Sciences University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2026-11 |
| Est. Completion | 2031-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07292298
The ClinicalTrials.gov registry entry for NCT07292298 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,166-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Rectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which High Rare Dose Rectal Brachytherapy Boost is the first listed.
NCT07292298 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Colorado, New York, Oregon.
Frequently Asked Questions
What is clinical trial NCT07292298 about?
NCT07292298 is a clinical study titled "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 comp...
What is the current status of trial NCT07292298?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2026-11. Estimated completion is 2031-11.
What conditions does trial NCT07292298 study?
This clinical trial studies the following conditions: Rectal Cancer, Rectal Adenocarcinoma.
What interventions are being tested in trial NCT07292298?
The interventions under investigation include: High Rare Dose Rectal Brachytherapy Boost (RADIATION).
Who is sponsoring clinical trial NCT07292298?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07292298 being conducted?
This trial has 3 study locations across Colorado, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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