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COLORII: COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

Sponsor
Jaap Bonjer (Other)
Overall Status
Unknown status
CT.gov ID
NCT00297791
Collaborator
(none)
1,100
Enrollment
35
Locations
1
Arm
160
Duration (Months)
31.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: surgery
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1100 participants
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.
Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Apr 1, 2013
Anticipated Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: 1

surgery (open or laparoscopic) and observation

Procedure: surgery
randomized to open or laparoscopic technique
Other Names:
  • observation following intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. locoregional recurrence rate [3 years post operatively]

    Secondary Outcome Measures

    1. survival free of cancer recurrence [three, five and seven years post-operatively]

    2. overall survival [three, five and seven years post-operatively]

    3. port-site and wound-site recurrences [annually for seven years]

    4. distant metastases rate [annually for seven years]

    5. operative mortality and morbidity [8 week or in-hospital]

    6. macroscopic evaluation of the resected specimen [post-operative]

    7. duration of in-hospital stay [post-operative]

    8. duration of absence of work [8 weeks and 6 months post-operatively]

    9. postoperative health related quality of life,including standardized questionnaires on sexual and bladder function [weekly for 8 weeks]

    10. in-hospital direct and indirect costs [seven years]

    11. out-of-hospital postoperative costs [seven years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Universitair Ziekenjuis Leuven Leuven Belgium
    2 Royal Alexandra Hospital, University of Alberta Edmonton Alberta Canada
    3 CDHA/ Dalhousie University Halifax Nova Scotia Canada B3H 2Y9
    4 University of Western Ontario London Ontario Canada
    5 Aalborg Hospital Aalborg Denmark
    6 SVS Esbjerg Esbjerg Denmark
    7 Amtssygehus i Gentofte Gentofte Denmark
    8 Hilleröd Hospital Hilleröd Denmark
    9 Odense Universitetshospital Odense Denmark
    10 Roskilde Hospital Roskilde Denmark
    11 Viborg Viborg Denmark
    12 Ludwig-Maximilians Universität Klinikum Großhadern München Germany
    13 Caritas-Krankenhaus St. Josef Regensburg Germany
    14 University Hospital Regensburg Regensburg Germany
    15 Marienhospital Stuttgart Germany
    16 Wuerzburg University Wuerzburg Germany
    17 Korea University Anam Hospital Seoul Korea, Republic of
    18 Academisch Medisch Centrum Amsterdam Netherlands
    19 Onze Lieve Vrouwe Gasthuis Amsterdam Netherlands
    20 VU Medisch Centrum Amsterdam Netherlands
    21 Jeroen Bosch Ziekenhuis Hertogenbosch Netherlands
    22 Rijnland Ziekenhuis Leiderdorp Netherlands
    23 Erasmus Medical Centre Rotterdam Netherlands
    24 Medisch Centrum Rijnmond-Zuid Rotterdam Netherlands
    25 Jagiellonian University Krakow Poland
    26 Hospital Clinic i Provencial de Barcelona Barcelona Spain
    27 Hospital de Sant Pau Barcelona Spain
    28 Hospital S.A.S. de Jerez Cadiz Spain
    29 Hospital del Sureste de Madrid Madrid Spain
    30 Arrixaca Hospital Universitario Murcia Spain
    31 Sahlgrenska University Hospital Göteborg Sweden
    32 Kärnsjukhuset Skvöde Sweden
    33 Ersta Hospital Stockholm Sweden
    34 Uddevalla Hospital Uddevalla Sweden
    35 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, Nova Scotia Health Authority

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jaap Bonjer, MD, PhD, Nova Scotia Health Authority
    ClinicalTrials.gov Identifier:
    NCT00297791
    Other Study ID Numbers:
    • CDHA007
    First Posted:
    Mar 1, 2006
    Last Update Posted:
    Jul 30, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Jaap Bonjer, MD, PhD, Nova Scotia Health Authority
    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

    Study Results

    No Results Posted as of Jul 30, 2013