6/28/23, 12:14 AM COLOR II Pathway Feedback Search Clinical Topics Home Studies COLOR II COLOR II Disease Rectal cancer Trial question Is laparoscopic surgery noninferior to open surgery in patients with rectal cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 37.0% female N = 1044 63.0% male 1044 patients (385 female, 659 male) Inclusion criteria: adult patients with rectal cancer within 15 cm from the anal verge without evidence of distant metastases Key exclusion criteria: T4 tumors or T3 tumors within 2 mm of the endopelvic fascia; T1 tumors treated by local excision; signs of acute intestinal obstruction; > 1 colorectal tumor Interventions N=699 laparoscopic surgery (laparoscopic-assisted rectal resection) N=345 open surgery (open laparotomy and rectal resection) Primary outcome Disease-free survival at 3 years 74.8 % 74.8 70.8 56.1 % https://web.pathway.md/studies/recx2VYsRGF3tDYnw 1/2 6/28/23, 12:14 AM COLOR II Pathway 37.4 % 18.7 % No significant difference 0.0 % Laparoscopic surgery Open surgery No significant difference in disease-free survival at 3 years (74.8% vs. 70.8%; AD 4%, 95% CI -1.9 to 9.9) Secondary outcomes No significant difference in overall survival at 3 years (86.7% vs. 83.6%; AD 3.1%, 95% CI -1.6 to 7.8) Conclusion In adult patients with rectal cancer within 15 cm from the anal verge without evidence of distant metastases, laparoscopic surgery was noninferior to open surgery with respect to a disease-free survival at 3 years. Reference H Jaap Bonjer, Charlotte L Deijen, Gabor A Abis et al. A Randomized Trial of Laparoscopic versus Open Surgery for Rectal Cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. Open reference URL https://web.pathway.md/studies/recx2VYsRGF3tDYnw 2/2