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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

Tracking Information
First Submitted Date  ICMJE January 21, 2008
First Posted Date  ICMJE February 4, 2008
Last Update Posted Date January 27, 2014
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
two-year disease free survival (DFS) [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2014)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
Overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, helath related quality of life, hospital length of stay [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Resection of Colorectal Metastases
Official Title  ICMJE Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 1, 2008)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606398
Other Study ID Numbers  ICMJE GIAW1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Alice Wei, UHN
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Sunnybrook Health Sciences Centre
Investigators  ICMJE
Principal Investigator: Alice Wei, MD, CM, MSc, FRCSC University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP