COlon Cancer Laparoscopic or Open Resection
|ClinicalTrials.gov Identifier: NCT00387842|
Recruitment Status : Unknown
Verified October 2006 by Erasmus Medical Center.
Recruitment status was: Active, not recruiting
First Posted : October 13, 2006
Last Update Posted : October 13, 2006
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms||Procedure: Laparoscopic surgery Procedure: Conventional surgery||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer|
|Study Start Date :||March 1997|
|Estimated Study Completion Date :||March 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387842
|Principal Investigator:||Jaap Bonjer, MD, PhD||Dalhousie University, CDHA / Erasmus MC Rotterdam|