COlon Cancer Laparoscopic or Open Resection

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Colonic Neoplasms

Clinical Trial Details

NCT number	NCT00387842
Study type	Interventional
Source	Erasmus Medical Center
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	March 1997
Completion date	March 2008

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