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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07292298
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • High Rare Dose Rectal Brachytherapy Boost — RADIATION
    HDR rectal brachytherapy boost using Iridium-192 delivered via an intracavitary applicator in three weekly fractions (total dose: 21 Gy) for patients with low-lying residual rectal adenocarcinoma following total neoadjuvant therapy.

Study Details

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.

Key Dates

Start date
Nov 30, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2030
Completion
Nov 30, 2031

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HDR Rectal Brachytherapy Boost
    The intervention consists of a boost using Iridium-192 delivered via an intracavitary applicator in three weekly fractions totaling 21 Gy. The goal is to improve organ preservation rates and avoid surgical resection (APR or low LAR). Treatment planning includes MRI, endoscopic clip placement, and CT simulation prior to each fraction.

Primary Outcome Measure

Organ preservation (no surgical requirement) of the rectum associated with complete clinical response [ Time Frame: 2 years following study treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045
Radiation Therapy Group
[email protected]
303-724-8822
David Binder, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical CenterRochesterNew York14642-
Oregon Health and Sciences UniversityPortlandOregon97239-

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