Phase 2 Study of Total Neoadjuvant Chemotherapy and Short-Course Radiation Therapy for Resectable Rectal Cancer

What this Trial Is About

The trial investigates total neoadjuvant therapy combining chemotherapy and short-course radiation in patients with resectable rectal cancer. It is a phase 2 study focusing on improving treatment outcomes before surgery or active surveillance for those with complete clinical response. The goal is to evaluate disease-free survival over three years after treatment or surgery. Participants receive four cycles of systemic chemotherapy with mFOLFOX6 before starting chemoradiotherapy, which includes pelvic intensity-modulated radiation therapy IMRT and continuous infusion of 5-fluorouracil 5-FU for four days. Following chemoradiotherapy, participants undergo consolidation with an additional four cycles of mFOLFOX6 before surgery or may opt for non-operative active surveillance if they achieve a complete clinical response. During the study, participants are monitored through clinical assessments, imaging, and biopsy to evaluate tumor response and safety. Researchers measure outcomes such as three-year disease-free survival, pathologic and clinical complete response rates, adverse events, progression-free survival, overall survival, and the need for ostomy at surgery. The trial involves careful observation for up to five years post-treatment to assess long-term effects.

Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer