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COLOR II: Laparoscopic Versus Open Rectal Cancer Removal (COLORII)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Jaap Bonjer, Capital District Health Authority, Canada.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00297791
First Posted: March 1, 2006
Last Update Posted: July 30, 2013
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.
Information provided by (Responsible Party):
Jaap Bonjer, Capital District Health Authority, Canada
  Purpose
COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.

Condition Intervention Phase
Rectal Cancer Procedure: surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

Further study details as provided by Jaap Bonjer, Capital District Health Authority, Canada:

Primary Outcome Measures:
  • locoregional recurrence rate [ Time Frame: 3 years post operatively ]

Secondary Outcome Measures:
  • survival free of cancer recurrence [ Time Frame: three, five and seven years post-operatively ]
  • overall survival [ Time Frame: three, five and seven years post-operatively ]
  • port-site and wound-site recurrences [ Time Frame: annually for seven years ]
  • distant metastases rate [ Time Frame: annually for seven years ]
  • operative mortality and morbidity [ Time Frame: 8 week or in-hospital ]
  • macroscopic evaluation of the resected specimen [ Time Frame: post-operative ]
  • duration of in-hospital stay [ Time Frame: post-operative ]
  • duration of absence of work [ Time Frame: 8 weeks and 6 months post-operatively ]
  • postoperative health related quality of life,including standardized questionnaires on sexual and bladder function [ Time Frame: weekly for 8 weeks ]
  • in-hospital direct and indirect costs [ Time Frame: seven years ]
  • out-of-hospital postoperative costs [ Time Frame: seven years ]

Estimated Enrollment: 1100
Study Start Date: June 2004
Estimated Study Completion Date: October 2017
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
surgery (open or laparoscopic) and observation
Procedure: surgery
randomized to open or laparoscopic technique
Other Name: observation following intervention

Detailed Description:

The design involves allocation of all suitable consecutive patients with rectal carcinoma to either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic procedure. Excluded are patients with a carcinoma treated by local resection and palliative resections. The trial will be stratified according to participating centre, resection type, and preoperative radiotherapy.

If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a difference greater than 5% in favor of the conventional procedure, non-inferiority of the laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases are required in total for a power of 80%.

Analysis will be primarily on an intention to treat basis. Definition of conversion is defined by protocol.

  Eligibility

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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • solitary rectal cancer observed at colonoscopy or on barium X-ray
  • no evidence of distant metastases
  • distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
  • suitable for elective surgical resection
  • informed consent

Exclusion Criteria:

  • T1 tumors treated by locl excision
  • T4 tumors
  • patients under 18 years of age
  • signs of acute intestinal obstruction
  • more than one colorectal tumor
  • Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
  • active crohn's or active ulcerative colitis
  • scheduled need for other synchronous colon surgery
  • preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
  • preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
  • other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
  • absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
  • 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): NCT00297791


  Show 35 Study Locations
Sponsors and Collaborators
Jaap Bonjer
Investigators
Principal Investigator: Jaap Bonjer, MD, PhD Dalhousie University, and VUMC, the Netherlands
Principal Investigator: Marius Hoogerboord Nova Scotia Health Authority
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaap Bonjer, MD, PhD, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00297791     History of Changes
Other Study ID Numbers: CDHA007
First Submitted: February 27, 2006
First Posted: March 1, 2006
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by Jaap Bonjer, Capital District Health Authority, Canada:
rectal cancer
laparoscopic technique
open technique
clinical trial
multicenter study
randomized controlled trial
Tumor Below 15cm
curative surgical resection
no evidence for distant metastases

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