COlon Cancer Laparoscopic or Open Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Ethicon Endo-Surgery
Information provided by:
Erasmus Medical Center

October 12, 2006
October 13, 2006
October 13, 2006
March 1997
Not Provided
Primary endpoint is cancer free survival at three years.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
COlon Cancer Laparoscopic or Open Resection
A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colonic Neoplasms
  • Procedure: Laparoscopic surgery
  • Procedure: Conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
March 2008
Not Provided

Inclusion Criteria:

  • Solitary colon carcinoma observed at colonoscopy or on barium enema X-ray within 28-days before operation (no biopsy required)
  • Polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken within 28 days before operation
  • Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy or sigmoid resection
  • Sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium enema
  • BMI < 30 kg/m2
  • Informed consent according to local requirements

Exclusion Criteria:

  • Carcinoma of the splenic flexure
  • Carcinoma of the transverse colon
  • Signs of acute intestinal obstruction
  • More than one colon tumour
  • Scheduled need for other synchronous colon surgery
  • Synchronous surgery ofr other intra-abdominal organs
  • Pre-operative indication of invasion of adjacent organs
  • Pre-operative evidence of distant metastases
  • Previous ipsilateral colon surgery
  • Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
  • Absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease
  • Pregnancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
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Erasmus Medical Center
Ethicon Endo-Surgery
Principal Investigator: Jaap Bonjer, MD, PhD Dalhousie University, CDHA / Erasmus MC Rotterdam
Erasmus Medical Center
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP