COLOR II
A randomized trial of laparoscopic versus open surgery for rectal cancer (COLOR II, COlorectal cancer Laparoscopic or Open Resection)
Phase 3N = 1,103NCT00297791
- Population
- Adults with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, without distant metastases
- Design
- International, multicentre, open-label, non-inferiority phase 3 trial at 30 hospitals in eight countries (January 2004 to May 2010). Patients with a solitary rectal adenocarcinoma within 15 cm of the anal verge, not invading adjacent tissues and without distant metastases were randomised 2:1 to laparoscopic or open surgery, stratified by centre, tumour location and preoperative radiotherapy. 1103 were randomised (739 laparoscopic, 364 open); 1044 were included in the analyses (699 and 345). Primary endpoint 3-year locoregional recurrence; secondary endpoints included disease-free and overall survival.
- Primary endpoint
- Locoregional recurrence after rectal surgery
- Arms
- Open surgery (control, n = 364): Open rectal cancer resection
- Laparoscopic surgery (experimental, n = 739): Laparoscopic rectal cancer resection
- People
- Bonjer HJ, COLOR II Study Group
Δ 36-month Locoregional recurrence after rectal surgery0 pointsΔ 36-month DFS+4 pointsΔ 36-month OS+3.1 pointsΔ Positive circumferential resection margin0 pointsΔ Surgical complications+3 points
Show the numbers
| Endpoint | Analysis | Laparoscopic surgery | Open surgery | Effect |
|---|---|---|---|---|
| Locoregional recurrence after rectal surgery1044 patients included in the analysis (699 laparoscopic, 345 open); analysis population otherwise not defined in the abstractRecurrence in the pelvic or perineal area 3 years after the index surgery (primary end point) | primaryBonjer 2015 | 5% at 3 y | 5% at 3 y | Difference 0 percentage points; 90% CI -2.6 to 2.6 (a 90% interval, as published). The non-inferiority margin is not stated in the abstract. |
| DFS1044 patients included in the analysis (699 laparoscopic, 345 open)3-year disease-free survival (secondary end point) | primaryBonjer 2015 | 74.8% at 3 y | 70.8% at 3 y | Difference 4.0 percentage points (95% CI -1.9 to 9.9), as published. |
| OS1044 patients included in the analysis (699 laparoscopic, 345 open)3-year overall survival (secondary end point) | primaryBonjer 2015 | 86.7% at 3 y | 83.6% at 3 y | Difference 3.1 percentage points (95% CI -1.6 to 7.8), as published. |
| Positive circumferential resection marginPatients with a pathologically assessed circumferential margin (588 laparoscopic, 300 open)Circumferential resection margin of less than 2 mm on pathological examination (short-term secondary outcome, reported before the primary endpoint matured) | interimvan 2013 | 10% | 10% | P=0.85056 of 588 laparoscopic and 30 of 300 open patients. |
| Surgical complicationsPatients with morbidity data (697 laparoscopic, 345 open)Morbidity within 28 days after surgery (short-term secondary outcome) | interimvan 2013 | 40% | 37% | P=0.424278 of 697 laparoscopic and 128 of 345 open patients. Mortality within 28 days: 8 of 699 (1%) vs 6 of 345 (2%), p=0.409. |
| Endpoint | Analysis | Laparoscopic surgery | Open surgery | Effect |
|---|---|---|---|---|
| Locoregional recurrence after rectal surgery1044 patients included in the analysis (699 laparoscopic, 345 open); analysis population otherwise not defined in the abstractRecurrence in the pelvic or perineal area 3 years after the index surgery (primary end point) | primaryBonjer 2015 | 5% at 3 y | 5% at 3 y | Difference 0 percentage points; 90% CI -2.6 to 2.6 (a 90% interval, as published). The non-inferiority margin is not stated in the abstract. |
| DFS1044 patients included in the analysis (699 laparoscopic, 345 open)3-year disease-free survival (secondary end point) | primaryBonjer 2015 | 74.8% at 3 y | 70.8% at 3 y | Difference 4.0 percentage points (95% CI -1.9 to 9.9), as published. |
| OS1044 patients included in the analysis (699 laparoscopic, 345 open)3-year overall survival (secondary end point) | primaryBonjer 2015 | 86.7% at 3 y | 83.6% at 3 y | Difference 3.1 percentage points (95% CI -1.6 to 7.8), as published. |
| Positive circumferential resection marginPatients with a pathologically assessed circumferential margin (588 laparoscopic, 300 open)Circumferential resection margin of less than 2 mm on pathological examination (short-term secondary outcome, reported before the primary endpoint matured) | interimvan 2013 | 10% | 10% | P=0.85056 of 588 laparoscopic and 30 of 300 open patients. |
| Surgical complicationsPatients with morbidity data (697 laparoscopic, 345 open)Morbidity within 28 days after surgery (short-term secondary outcome) | interimvan 2013 | 40% | 37% | P=0.424278 of 697 laparoscopic and 128 of 345 open patients. Mortality within 28 days: 8 of 699 (1%) vs 6 of 345 (2%), p=0.409. |
Appears in
Sources
Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, et al. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015;372(14):1324-32.
van der Pas MH, Haglind E, Cuesta MA, Fürst A, Lacy AM, Hop WC, et al. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013;14(3):210-8.