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Trial record 84 of 1009 for:    colon cancer AND resection

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.
 
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
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Erasmus Medical Center

Tracking Information
First Submitted Date  ICMJE October 12, 2006
First Posted Date  ICMJE October 13, 2006
Last Update Posted Date October 13, 2006
Study Start Date  ICMJE March 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2006)
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
 (submitted: October 12, 2006)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonic Neoplasms
Intervention  ICMJE
  • Procedure: Laparoscopic surgery
  • Procedure: Conventional surgery
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: October 12, 2006)
1200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2008
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387842
Other Study ID Numbers  ICMJE COLOR I
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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
PRS Account 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