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

August 19, 2024 updated by: Nova Scotia Health Authority

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1044

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • Universitair Ziekenjuis Leuven
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital, University of Alberta
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • CDHA/ Dalhousie University
    • Ontario
      • London, Ontario, Canada
        • University of Western Ontario
  • Denmark
      • Aalborg, Denmark
        • Aalborg Hospital
      • Esbjerg, Denmark
        • SVS Esbjerg
      • Gentofte, Denmark
        • Amtssygehus i Gentofte
      • Hilleröd, Denmark
        • Hillerod Hospital
      • Odense, Denmark
        • Odense Universitetshospital
      • Roskilde, Denmark
        • Roskilde Hospital
      • Viborg, Denmark
        • Viborg
  • Germany
      • München, Germany
        • Ludwig-Maximilians Universität Klinikum Großhadern
      • Regensburg, Germany
        • Caritas-Krankenhaus St. Josef
      • Regensburg, Germany
        • University Hospital Regensburg
      • Stuttgart, Germany
        • Marienhospital
      • Wuerzburg, Germany
        • Wuerzburg University
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • VU Medisch Centrum
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum
      • Hertogenbosch, Netherlands
        • Jeroen Bosch Ziekenhuis
      • Leiderdorp, Netherlands
        • Rijnland Ziekenhuis
      • Rotterdam, Netherlands
        • Erasmus Medical Centre
      • Rotterdam, Netherlands
        • Medisch Centrum Rijnmond-Zuid
  • Poland
      • Krakow, Poland
        • Jagiellonian University
  • Spain
      • Barcelona, Spain
        • Hospital de Sant Pau
      • Barcelona, Spain
        • Hospital Clinic i Provencial de Barcelona
      • Cadiz, Spain
        • Hospital S.A.S. de Jerez
      • Madrid, Spain
        • Hospital del Sureste de Madrid
      • Murcia, Spain
        • Arrixaca Hospital Universitario
  • Sweden
      • Göteborg, Sweden
        • Sahlgrenska University Hospital
      • Skvöde, Sweden
        • Kärnsjukhuset
      • Stockholm, Sweden
        • Ersta Hospital
      • Uddevalla, Sweden
        • Uddevalla Hospital
      • Örebro, Sweden
        • Örebro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
surgery (open or laparoscopic) and observation
Procedure: surgery
randomized to open or laparoscopic technique
Other Names:
  • observation following intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
locoregional recurrence rate
Time Frame: 3 years post operatively
3 years post operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
survival free of cancer recurrence
Time Frame: three, five and seven years post-operatively
three, five and seven years post-operatively
overall survival
Time Frame: three, five and seven years post-operatively
three, five and seven years post-operatively
port-site and wound-site recurrences
Time Frame: annually for seven years
annually for seven years
distant metastases rate
Time Frame: annually for seven years
annually for seven years
operative mortality and morbidity
Time Frame: 8 week or in-hospital
8 week or in-hospital
macroscopic evaluation of the resected specimen
Time Frame: post-operative
post-operative
duration of in-hospital stay
Time Frame: post-operative
post-operative
duration of absence of work
Time Frame: 8 weeks and 6 months post-operatively
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
weekly for 8 weeks
in-hospital direct and indirect costs
Time Frame: seven years
seven years
out-of-hospital postoperative costs
Time Frame: seven years
seven years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Jaap Bonjer, MD, PhD, Dalhousie University, and VUMC, the Netherlands
  • Principal Investigator: Marius Hoogerboord, Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimated)

March 1, 2006

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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