COlon Cancer Laparoscopic or Open Resection - Full Text View

Sponsor:	Erasmus Medical Center
Collaborator:	Ethicon Endo-Surgery
Information provided by:	Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00387842

Purpose

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.

Condition	Intervention	Phase
Colonic Neoplasms	Procedure: Laparoscopic surgery Procedure: Conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:

Primary endpoint is cancer free survival at three years.

Secondary Outcome Measures:

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.

Estimated Enrollment:	1200
Study Start Date:	March 1997
Estimated Study Completion Date:	March 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387842

Sponsors and Collaborators

Erasmus Medical Center

Ethicon Endo-Surgery

Investigators

Principal Investigator:

Jaap Bonjer, MD, PhD

Dalhousie University, CDHA / Erasmus MC Rotterdam

More Information

No publications provided by Erasmus Medical Center

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	COLOR I
Study First Received:	October 12, 2006
Last Updated:	October 12, 2006
ClinicalTrials.gov Identifier:	NCT00387842 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 05, 2009