Phase III Study Comparing Two Radiation Boost Methods to Preserve the Rectum in Patients with Stage II-III Rectal Cancer After Chemoradiation

What this Trial Is About

Researchers are investigating the best radiation dose escalation methods to treat stage II-III rectal cancer without surgery. This phase III randomized study focuses on patients with clinical T2-3 N0-1 rectal cancer, aiming to preserve the rectum by comparing two radiotherapy boost approaches after standard chemoradiation. The study addresses the needs of an older patient population with multiple health conditions and excludes those with advanced or metastatic disease. Participants are randomly assigned to one of two groups one receives standard chemoradiation 45 Gy in 25 sessions with chemotherapy using 5-FU or Xeloda plus an external beam radiation boost of 9 Gy in 5 fractions, while the other group receives the same chemoradiation followed by a brachytherapy boost of 30 Gy delivered in 3 fractions. Patients who respond completely to the treatment avoid surgery, whereas those who do not achieve a complete response will undergo surgery. Throughout the study, participants undergo assessments to monitor rectum preservation and treatment response, with primary outcomes measured by two-year survival without total mesorectal excision TME. Secondary outcomes include local recurrence, disease-free survival, overall survival, and quality of life evaluated over five years. The study involves regular evaluations to determine treatment effects and safety, with the total study period extending through 2030.

Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery