COlon Cancer Laparoscopic or Open Resection - Tabular View

Tracking Information

First Received Date ^ICMJE

October 12, 2006

Last Updated Date

October 12, 2006

Start Date ^ICMJE

March 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Primary endpoint is cancer free survival at three years.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

COlon Cancer Laparoscopic or Open Resection

Official Title ^ICMJE

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer

Brief 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.

Detailed 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Condition ^ICMJE

Colonic Neoplasms

Intervention ^ICMJE

Procedure: Laparoscopic surgery
Procedure: Conventional surgery

Study Arms / Comparison Groups

Publications *

Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Påhlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. Epub 2008 Dec 13.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

1200

Completion Date

March 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00387842

Responsible Party

Study ID Numbers ^ICMJE

COLOR I

Study Sponsor ^ICMJE

Erasmus Medical Center

Collaborators ^ICMJE

Ethicon Endo-Surgery

Investigators ^ICMJE

Principal Investigator:

Jaap Bonjer, MD, PhD

Dalhousie University, CDHA / Erasmus MC Rotterdam

Information Provided By

Erasmus Medical Center

Verification Date

October 2006

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