COLOR II
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
63.0% male
N = 1044
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
Locoregional recurrence at 3 years
5%
5%
5.0 %
3.8 %
2.5 %
1.3 %
0.0 %
Laparoscopic
surgery
Open
surgery
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in locoregional recurrence at 3 years (5% vs. 5%).
Secondary outcomes
No significant difference in disease-free survival at 3 years (74.8% vs. 70.8%; AD 4%, 95% CI -1.9 to 9.9).
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 locoregional recurrence 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.
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