Comparing Surgery Timing After Chemoradiotherapy for Rectal Cancer A Multicenter Randomized Trial of Minimally Invasive Surgery at 8 Versus 12 Weeks

What this Trial Is About

Researchers are investigating the impact of the timing of minimally invasive surgery after neoadjuvant chemoradiotherapy for rectal cancer. This multicenter, randomized controlled trial aims to determine whether delaying surgery from the standard 8 weeks to 12 weeks influences the pathological complete response pCR, disease-free survival DFS, and overall survival OS in patients with locally advanced rectal cancer. The trial also explores the quality of life QoL outcomes related to these treatment intervals. Participants are randomly assigned to one of two groups one undergoes minimally invasive surgery, including robotic-assisted or standard laparoscopic procedures, 8 weeks after chemoradiation, and the other 12 weeks after. The trial includes surgeries such as low anterior resection, intersphincteric resection, or abdominoperineal resection using various robotic systems or standard laparoscopic methods. The study involves a recruitment period of 5 years with follow-up continuing for 5 years after the last patient is randomized. During the study, patients will complete questionnaires and undergo preoperative assessments including CT-scan and MRI to confirm tumor staging. Researchers will monitor outcomes including pathological response, survival rates, and quality of life. Patients provide informed consent and are evaluated for eligibility before randomization, which occurs near the start of neoadjuvant treatment. Safety and treatment effects are tracked throughout the study period, which may last up to 10 years including follow-up.

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer