Safety and efficacy of preoperative chemotherapy for obstructive colon cancer with endoscopic stenting: SUCCEED study.

[AIMS] Self-expanding metal stents (SEMS) are widely used as a bridge to surgery in obstructive colon cancer, offering short-term benefits by reducing postoperative complications and avoiding emergency stoma creation. Additionally, early initiation of systemic chemotherapy may improve oncological outcomes. However, the safety and feasibility of preoperative chemotherapy following SEMS placement remain unclear. This study aims to evaluate the safety and efficacy of neoadjuvant CAPOX chemotherapy after SEMS placement in patients with obstructive colon cancer.

[PATIENTS & METHODS] This is a prospective, multicenter, single-arm Phase II trial involving patients with clinical stage II or III obstructive colon cancer. Eligible patients undergo successful SEMS placement followed by two cycles of CAPOX chemotherapy prior to elective surgery. The primary endpoint is the incidence of severe perioperative complications, defined as a composite of stent-related adverse events and Clavien - Dindo Grade III or higher postoperative complications. Secondary endpoints include chemotherapy-related adverse events, pathological response, and 2-year relapse-free survival. A total of 75 patients are planned for enrollment across 16 hospitals in Japan over 1.5 years. The study is registered in the Japan Registry of Clinical Trials (jRCTs051240077).