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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jaap Bonjer, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00297791
First received: February 27, 2006
Last updated: July 29, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • locoregional recurrence rate [ Time Frame: 3 years post operatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • survival free of cancer recurrence [ Time Frame: three, five and seven years post-operatively ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: three, five and seven years post-operatively ] [ Designated as safety issue: No ]
  • port-site and wound-site recurrences [ Time Frame: annually for seven years ] [ Designated as safety issue: No ]
  • distant metastases rate [ Time Frame: annually for seven years ] [ Designated as safety issue: No ]
  • operative mortality and morbidity [ Time Frame: 8 week or in-hospital ] [ Designated as safety issue: No ]
  • macroscopic evaluation of the resected specimen [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • duration of in-hospital stay [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • duration of absence of work [ Time Frame: 8 weeks and 6 months post-operatively ] [ Designated as safety issue: No ]
  • postoperative health related quality of life,including standardized questionnaires on sexual and bladder function [ Time Frame: weekly for 8 weeks ] [ Designated as safety issue: No ]
  • in-hospital direct and indirect costs [ Time Frame: seven years ] [ Designated as safety issue: No ]
  • out-of-hospital postoperative costs [ Time Frame: seven years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297791

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

No publications provided by Capital District Health Authority, Canada

Additional 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
Study First Received: February 27, 2006
Last Updated: July 29, 2013
Health Authority: Canada: Health Canada

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014