NCT00297791

COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,044 (actual)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.

Detailed description

The design involves allocation of all suitable consecutive patients with rectal carcinoma to either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic procedure. Excluded are patients with a carcinoma treated by local resection and palliative resections. The trial will be stratified according to participating centre, resection type, and preoperative radiotherapy. If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a difference greater than 5% in favor of the conventional procedure, non-inferiority of the laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases are required in total for a power of 80%. Analysis will be primarily on an intention to treat basis. Definition of conversion is defined by protocol.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	surgery	randomized to open or laparoscopic technique

Timeline

• Start date: 2004-06-01
• Primary completion: 2013-04-01
• Completion: 2015-09-01
• First posted: 2006-03-01
• Last updated: 2024-08-21

Locations

35 sites across 9 countries: Belgium, Canada, Denmark, Germany, Netherlands, Poland, South Korea, Spain, Sweden