COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

Last updated: August 19, 2024
Sponsor: Nova Scotia Health Authority
Overall Status: Completed

Phase

3

Condition

Colorectal Cancer

Digestive System Neoplasms

Colon Cancer

Treatment

surgery

Clinical Study ID

NCT00297791
CDHA007
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orunder linea conjugata at lateral barium enema radiography

  • suitable for elective surgical resection

  • informed consent

Exclusion

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 CTshowing invasion

  • preoperative evidence of metastases (at least chest X-ray and liver ultrasound)

  • other malignancies in medical history except adequately treated basocellularcarcinoma of the skin or in situ carcinoma of the cervix uteri

  • absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASAclass > III)

  • pregnancy

Study Design

Total Participants: 1044
Treatment Group(s): 1
Primary Treatment: surgery
Phase: 3
Study Start date:
June 01, 2004
Estimated Completion Date:
September 30, 2015

Study 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.

Connect with a study center

  • Universitair Ziekenjuis Leuven

    Leuven,
    Belgium

    Site Not Available

  • Royal Alexandra Hospital, University of Alberta

    Edmonton, Alberta
    Canada

    Site Not Available

  • CDHA/ Dalhousie University

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • University of Western Ontario

    London, Ontario
    Canada

    Site Not Available

  • Aalborg Hospital

    Aalborg,
    Denmark

    Site Not Available

  • SVS Esbjerg

    Esbjerg,
    Denmark

    Site Not Available

  • Amtssygehus i Gentofte

    Gentofte,
    Denmark

    Site Not Available

  • Hilleröd Hospital

    Hilleröd,
    Denmark

    Site Not Available

  • Hilleröd Hospital

    Hilleröd,
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense,
    Denmark

    Site Not Available

  • Roskilde Hospital

    Roskilde,
    Denmark

    Site Not Available

  • Viborg

    Viborg,
    Denmark

    Site Not Available

  • Ludwig-Maximilians Universität Klinikum Großhadern

    München,
    Germany

    Site Not Available

  • Ludwig-Maximilians Universität Klinikum Großhadern

    München,
    Germany

    Site Not Available

  • Caritas-Krankenhaus St. Josef

    Regensburg,
    Germany

    Site Not Available

  • University Hospital Regensburg

    Regensburg,
    Germany

    Site Not Available

  • Marienhospital

    Stuttgart,
    Germany

    Site Not Available

  • Wuerzburg University

    Wuerzburg,
    Germany

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Academisch Medisch Centrum

    Amsterdam,
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam,
    Netherlands

    Site Not Available

  • VU Medisch Centrum

    Amsterdam,
    Netherlands

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    Hertogenbosch,
    Netherlands

    Site Not Available

  • Rijnland Ziekenhuis

    Leiderdorp,
    Netherlands

    Site Not Available

  • Erasmus Medical Centre

    Rotterdam,
    Netherlands

    Site Not Available

  • Medisch Centrum Rijnmond-Zuid

    Rotterdam,
    Netherlands

    Site Not Available

  • Jagiellonian University

    Krakow,
    Poland

    Site Not Available

  • Hospital Clinic i Provencial de Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital de Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital S.A.S. de Jerez

    Cadiz,
    Spain

    Site Not Available

  • Hospital del Sureste de Madrid

    Madrid,
    Spain

    Site Not Available

  • Arrixaca Hospital Universitario

    Murcia,
    Spain

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg,
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg,
    Sweden

    Site Not Available

  • Kärnsjukhuset

    Skvöde,
    Sweden

    Site Not Available

  • Kärnsjukhuset

    Skvöde,
    Sweden

    Site Not Available

  • Ersta Hospital

    Stockholm,
    Sweden

    Site Not Available

  • Uddevalla Hospital

    Uddevalla,
    Sweden

    Site Not Available

  • Örebro Hospital

    Örebro,
    Sweden

    Site Not Available

  • Örebro Hospital

    Örebro,
    Sweden

    Site Not Available

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