COlon Cancer Laparoscopic or Open Resection
Recruitment status was: Active, not recruiting
|Colonic Neoplasms||Procedure: Laparoscopic surgery Procedure: Conventional surgery||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer|
- Primary endpoint is cancer free survival at three years.
- Secondary endpoints are overall survival at three and five years, 28 day mortality and morbidity, quality of life, costs, location and rates of recurrences and pathologic anatomic characteristics of the resected specimen.
|Study Start Date:||March 1997|
|Estimated Study Completion Date:||March 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387842
|Principal Investigator:||Jaap Bonjer, MD, PhD||Dalhousie University, CDHA / Erasmus MC Rotterdam|