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COlon Cancer Laparoscopic or Open Resection

Primary Purpose

Colonic Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Laparoscopic surgery
Conventional surgery
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Solitary colon carcinoma observed at colonoscopy or on barium enema X-ray within 28-days before operation (no biopsy required)
  • Polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken within 28 days before operation
  • Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy or sigmoid resection
  • Sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium enema
  • BMI < 30 kg/m2
  • Informed consent according to local requirements

Exclusion Criteria:

  • Carcinoma of the splenic flexure
  • Carcinoma of the transverse colon
  • Signs of acute intestinal obstruction
  • More than one colon tumour
  • Scheduled need for other synchronous colon surgery
  • Synchronous surgery ofr other intra-abdominal organs
  • Pre-operative indication of invasion of adjacent organs
  • Pre-operative evidence of distant metastases
  • Previous ipsilateral colon surgery
  • Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
  • Absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease
  • Pregnancy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Primary endpoint is cancer free survival at three years.

    Secondary Outcome Measures

    Secondary endpoints are overall survival at three and five years, 28 day mortality and morbidity, quality of life, costs, location and rates of recurrences and pathologic anatomic characteristics of the resected specimen.

    Full Information

    First Posted
    October 12, 2006
    Last Updated
    October 12, 2006
    Sponsor
    Erasmus Medical Center
    Collaborators
    Ethicon Endo-Surgery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00387842
    Brief Title
    COlon Cancer Laparoscopic or Open Resection
    Official Title
    A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1997 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2008 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Erasmus Medical Center
    Collaborators
    Ethicon Endo-Surgery

    4. Oversight

    5. Study Description

    Brief Summary
    COLOR trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Rotterdam, The Netherlands. Quality of life and costs will be assessed on a national basis.
    Detailed Description
    The design involves allocation of all suitable consecutive patients with colon carcinoma to either of the two procedures at a randomization ratio of 1:1. The trial will be stratified according to participating centre, resection type and gender. Disease free survival for all TNM stages after 3 years is currently about 70%. To detect a difference of 7% in disease free survival rate after 3 years between open and laparoscopic resection of colon cancer, 1200 patients will have to be included (60 vs 67%, two-sided analysis; alfa=0.05, beta=0.20, power=80% and p=0.05). All analyses will be performed on an intention to treat basis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1200 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional surgery
    Primary Outcome Measure Information:
    Title
    Primary endpoint is cancer free survival at three years.
    Secondary Outcome Measure Information:
    Title
    Secondary endpoints are overall survival at three and five years, 28 day mortality and morbidity, quality of life, costs, location and rates of recurrences and pathologic anatomic characteristics of the resected specimen.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Solitary colon carcinoma observed at colonoscopy or on barium enema X-ray within 28-days before operation (no biopsy required) Polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken within 28 days before operation Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy or sigmoid resection Sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium enema BMI < 30 kg/m2 Informed consent according to local requirements Exclusion Criteria: Carcinoma of the splenic flexure Carcinoma of the transverse colon Signs of acute intestinal obstruction More than one colon tumour Scheduled need for other synchronous colon surgery Synchronous surgery ofr other intra-abdominal organs Pre-operative indication of invasion of adjacent organs Pre-operative evidence of distant metastases Previous ipsilateral colon surgery Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri Absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaap Bonjer, MD, PhD
    Organizational Affiliation
    Dalhousie University, CDHA / Erasmus MC Rotterdam
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32224742
    Citation
    Koedam TWA, Bootsma BT, Deijen CL, van de Brug T, Kazemier G, Cuesta MA, Furst A, Lacy AM, Haglind E, Tuynman JB, Daams F, Bonjer HJ; on behalf of the COLOR COLOR II study group. Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence. Ann Surg. 2022 Feb 1;275(2):e420-e427. doi: 10.1097/SLA.0000000000003889.
    Results Reference
    derived
    PubMed Identifier
    27734203
    Citation
    Deijen CL, Vasmel JE, de Lange-de Klerk ESM, Cuesta MA, Coene PLO, Lange JF, Meijerink WJHJ, Jakimowicz JJ, Jeekel J, Kazemier G, Janssen IMC, Pahlman L, Haglind E, Bonjer HJ; COLOR (COlon cancer Laparoscopic or Open Resection) study group. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer. Surg Endosc. 2017 Jun;31(6):2607-2615. doi: 10.1007/s00464-016-5270-6. Epub 2016 Oct 12.
    Results Reference
    derived
    PubMed Identifier
    19071061
    Citation
    Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.
    Results Reference
    derived

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    COlon Cancer Laparoscopic or Open Resection

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