COLOR: trial | Bending the Curve: Trial by Trial

COLOR

COlon cancer Laparoscopic or Open Resection (COLOR)

Population

1248 patients randomised (627 laparoscopic, 621 open); 172 excluded after randomisation, mainly for distant metastases or benign disease, leaving 1076 eligible for analysis (534 laparoscopic, 542 open).

Design

Non-inferiority randomised trial at 29 European hospitals (recruitment 7 March 1997 to 6 March 2003) of laparoscopic versus open surgery as curative treatment of a solitary cancer of the right or left colon, with a body-mass index up to 30 kg/m2. Primary outcome disease-free survival 3 years after surgery with a prespecified non-inferiority boundary of 7% difference between groups; neither patients nor health-care providers were blinded; analysis by intention to treat (abstract). Registered NCT00387842; the registry lists phase 3 and 1200 enrolment.

Primary endpoint

DFS

Arms

Open surgery (control, n = 621): Open resection of colon cancer
Laparoscopic surgery (experimental, n = 627): Laparoscopic resection of colon cancer

People

Colon Cancer Laparoscopic or Open Resection Study Group, Colon Cancer Laparoscopic or Open Resection Study Group

DFSHR 0.92 (95% CI 0.74–1.15)Δ 36-month DFS−2 pointsOSHR 0.95 (95% CI 0.74–1.22)Δ 36-month OS−2.4 points

Show the numbers

Results reported for COLOR
Endpoint	Analysis	Laparoscopic surgery	Open surgery	Effect
DFSPatients eligible for analysis after post-randomisation exclusions (1076 of 1248 randomised); the abstract states analysis by intention to treat	primarymedian follow-up 53 monthsColon 2009	74.2% at 3 y (70.4–78.0%)	76.2% at 3 y (72.6–79.8%)	HR 0.92 (95% CI 0.74–1.15)P=0.70The hazard ratio is published for open versus laparoscopic surgery. The difference in 3-year DFS was 2.0% (95% CI -3.2 to 7.2); the authors state that the upper limit of the interval just exceeded the predefined non-inferiority boundary of 7%, so the trial could not rule out a difference favouring open colectomy.
OSPatients eligible for analysis after post-randomisation exclusions (1076 of 1248 randomised); the abstract states analysis by intention to treat	primarymedian follow-up 53 monthsColon 2009	81.8% at 3 y (78.4–85.1%)	84.2% at 3 y (81.1–87.3%)	HR 0.95 (95% CI 0.74–1.22)P=0.45Difference in 3-year OS 2.4% (95% CI -2.1 to 7.0). The abstract does not restate the comparison direction of this hazard ratio.

Results reported for COLOR
Endpoint	Analysis	Laparoscopic surgery	Open surgery	Effect
DFSPatients eligible for analysis after post-randomisation exclusions (1076 of 1248 randomised); the abstract states analysis by intention to treat	primarymedian follow-up 53 monthsColon 2009	74.2% at 3 y (70.4–78.0%)	76.2% at 3 y (72.6–79.8%)	HR 0.92 (95% CI 0.74–1.15)P=0.70The hazard ratio is published for open versus laparoscopic surgery. The difference in 3-year DFS was 2.0% (95% CI -3.2 to 7.2); the authors state that the upper limit of the interval just exceeded the predefined non-inferiority boundary of 7%, so the trial could not rule out a difference favouring open colectomy.
OSPatients eligible for analysis after post-randomisation exclusions (1076 of 1248 randomised); the abstract states analysis by intention to treat	primarymedian follow-up 53 monthsColon 2009	81.8% at 3 y (78.4–85.1%)	84.2% at 3 y (81.1–87.3%)	HR 0.95 (95% CI 0.74–1.22)P=0.45Difference in 3-year OS 2.4% (95% CI -2.1 to 7.0). The abstract does not restate the comparison direction of this hazard ratio.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
DFS	0.92	0.74–1.15
OS	0.95	0.74–1.22

Appears in

2004 Laparoscopic versus open colectomy: COST, CLASICC, COLOR, JCOG0404

Sources

Colon Cancer Laparoscopic or Open Resection Study Group, Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, et al. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009;10(1):44-52.
PubMed DOI