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COlon Cancer Laparoscopic or Open Resection

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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:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Procedure: Laparoscopic surgery Procedure: Conventional surgery Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer
Study Start Date : March 1997
Estimated Study Completion Date : March 2008
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Primary endpoint is cancer free survival at three years.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00387842     History of Changes
Other Study ID Numbers: COLOR I
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: October 13, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases