Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

COlon Cancer Laparoscopic or Open Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Erasmus Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00387842
First received: October 12, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted

October 12, 2006
October 12, 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colonic Neoplasms
  • Procedure: Laparoscopic surgery
  • Procedure: Conventional surgery
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00387842
COLOR I
Not Provided
Not Provided
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