Study Comparing Contact X-ray Brachytherapy Versus Waiting Longer and Local Excision for Preserving the Rectum in Patients With Good Response After Chemoradiation for Rectal Cancer

What this Trial Is About

Researchers are exploring ways to preserve the rectum in patients with rectal cancer who show a good clinical response after neoadjuvant chemoradiation. This phase II feasibility study compares two local treatment approaches contact x-ray brachytherapy versus extending the waiting period with or without local excision. The goal is to determine how often organ preservation can be achieved and to optimize treatment strategies for patients with a near-complete response or small residual tumor. The study includes two experimental groups. In one group, contact x-ray brachytherapy is delivered as three 30 Gy fractions to the tumor within 14 weeks after completing chemoradiation, with two-week intervals between doses. Patients are monitored every three months afterward. The other group extends the waiting interval by 6 to 8 weeks after the initial response evaluation, with additional assessments to check for tumor response. Patients showing complete response enter a watch-and-wait approach, while those with small remaining lesions may receive local excision, followed by risk-based recommendations for further treatment. Participants undergo regular clinical, radiological, and endoscopic assessments to monitor tumor response and detect any disease progression. The primary outcome is the rate of successful organ preservation one year after randomization. Secondary outcomes include treatment-related toxicity, postoperative complications, bowel and bladder function, quality of life, tumor regrowth, disease-free survival, and overall survival measured up to five years. An intensive follow-up program supports early detection of recurrence and timely surgical intervention if needed.

Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision