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Recruiting NCT06501053

Contact Radiotherapy for Rectal Cancer

Trial Parameters

Condition Rectal Cancer
Sponsor Alexander Valdman
Study Type INTERVENTIONAL
Phase N/A
Enrollment 110
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-03
Completion 2030-04
Interventions
RadiotherapyShort-course radiotherapyContact x-ray brachytherapy

Brief Summary

The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).

Eligibility Criteria

Inclusion Criteria: * Adenocarcinoma of the rectum classified as: * cT1-cT3ab, \< 5 cm largest diameter and \< ½ circumference (MRI staging), N0-N1 (\<= 3 nodes \< 8mm diameter), M0 * Performance status (ECOG) 0-1 * Operable patient * Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm * 18 years or above * No comorbidity preventing treatment * Patient having read the information note and having signed the informed consent * Follow-up possible Exclusion Criteria: * Inoperable patient * T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference * Distance from the lower tumor border to the anal verge \>10 cm * N2-status at diagnosis or N1 with any node\>= 8 mm diameter * Patient presenting with metastasis at diagnosis (M1) * Previous pelvic irradiation * Tumor with extramural vascular invasion * Poorly differentiated tumor * Simultaneous progressive cancer * Tumor invading external anal sphinct

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