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Combined Resection of Colorectal Metastases (CRC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606398
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : January 27, 2014
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by:
University Health Network, Toronto

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Procedure: surgical resection for patients with both intra- and extra-hepatic metastases Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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

Outcome Measures
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Primary Outcome Measures :
  1. two-year disease free survival (DFS) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606398


Locations
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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Alice Wei, MD, CM, MSc, FRCSC University Health Network, Toronto
More Information
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Responsible Party: Dr. Alice Wei, UHN
ClinicalTrials.gov Identifier: NCT00606398    
Other Study ID Numbers: GIAW1
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014
Keywords provided by University Health Network, Toronto:
colorectal metastases
Additional relevant MeSH terms:
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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