Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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) 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-100 lat
- •Rak odbytnicy w dolnych partiach, który nie całkowicie znikł po chemioterapii i radioterapii
- •Pozostały nowotwór mały (poniżej 4 cm długości, poniżej 1,2 cm grubości)
- •Nowotwór zajmuje mniej niż połowę obwodu ścianki odbytnicy
- •Ukończona terapia neoadiuwantna 4-16 tygodni wcześniej
- •Zdolność do uczestnictwa we wszystkich wizytach badania
- •Brak poważnych zaburzeń kontroli zwieraczy
- •Kobiery w wieku rozrodczym muszą mieć ujemny test ciąży
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 100 Years
- Last updated (source)
- September 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (3)
University of Colorado Cancer Center
Aurora, United States
University of Rochester Medical Center
Rochester, United States
Oregon Health and Sciences University
Portland, United States
Trial contact
Radiation Therapy Group
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/3/2026.
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