Combined Resection of Colorectal Metastases (CRC)

This study has been completed.
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00606398
First received: January 21, 2008
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

This is a Phase II study of combined surgical resection for patients with both intra- and extra-hepatic metastases from colorectal cancer. The primary objective is to determine the two-year disease free survival (DFS) of patients who undergo surgical resection of both intra- and extra-hepatic metastases from colorectal cancer. The secondary objectives are to determine the overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, and hospital length of stay.


Condition Intervention Phase
Colorectal Cancer
Procedure: surgical resection for patients with both intra- and extra-hepatic metastases
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • two-year disease free survival (DFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, hospital length of stay [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: June 2007
Study Completion Date: January 2014
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: surgical resection for patients with both intra- and extra-hepatic metastases
    Simultaneous resection with R0 intent of intra-abdominal metastases from CRC. For patients with extra-abdominal disease, sequential resection will be permitted
Detailed Description:

This phase II clinical study will examine the outcomes of surgical therapy for patients with both intra- and extra-hepatic CRC metastases.

The treatment protocol includes surgical resection of metastases from Colorectal cancer. Multi-modality co-interventions such as chemotherapy (neo-adjuvant, or post-operative), radiofrequency ablation (RFA) and/or portal vein embolization (PVE) will be permitted.

The eligibility criteria include: patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer, the number of extra-hepatic metastases must be three or less on pre-operative imaging, all metastatic deposits must be resectable with R0 intent, there must be no contra-indications to major surgery and an ECOG performance status of 0, 1 or 2.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer
  • Number of extra-hepatic metastases must be 3 or less on pre-operative imaging
  • All metastatic deposits must be resectable with clear margins
  • No contra-indications to major surgery
  • ECOG performance of 0, 1 or 2
  • Age 18 or older
  • Pregnant women or women of childbearing potential are eligible if they agree to use 2 methods of effective contraception during treatment protocol
  • Written informed consent can be obtained

Exclusion Criteria:

  • Colorectal primary in situ
  • Four or more extra-hepatic lesions on pre-operative imaging
  • Significant medical or psychiatric conditions that preclude major surgery or may interfere with patient compliance
  • Patients receiving investigational drugs with unknown surgical risks
  • Failure to meet inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606398

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Alice Wei, MD, CM, MSc, FRCSC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Alice Wei, UHN
ClinicalTrials.gov Identifier: NCT00606398     History of Changes
Other Study ID Numbers: GIAW1
Study First Received: January 21, 2008
Last Updated: January 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
colorectal metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014