NCT00387842

COlon Cancer Laparoscopic or Open Resection

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (planned)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

COLOR trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Rotterdam, The Netherlands. Quality of life and costs will be assessed on a national basis.

Detailed description

The design involves allocation of all suitable consecutive patients with colon carcinoma to either of the two procedures at a randomization ratio of 1:1. The trial will be stratified according to participating centre, resection type and gender. Disease free survival for all TNM stages after 3 years is currently about 70%. To detect a difference of 7% in disease free survival rate after 3 years between open and laparoscopic resection of colon cancer, 1200 patients will have to be included (60 vs 67%, two-sided analysis; alfa=0.05, beta=0.20, power=80% and p=0.05). All analyses will be performed on an intention to treat basis.

Conditions

• Colonic Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic surgery
PROCEDURE	Conventional surgery

Timeline

• Start date: 1997-03-01
• Completion: 2008-03-01
• First posted: 2006-10-13
• Last updated: 2006-10-13