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Combined Resection of Colorectal Metastases (CRC)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
surgical resection for patients with both intra- and extra-hepatic metastases
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network

Outcomes

Primary Outcome Measures

two-year disease free survival (DFS)

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

Full Information

First Posted
January 21, 2008
Last Updated
January 24, 2014
Sponsor
University Health Network, Toronto
Collaborators
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00606398
Brief Title
Combined Resection of Colorectal Metastases
Acronym
CRC
Official Title
Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
surgical resection for patients with both intra- and extra-hepatic metastases
Intervention Description
Simultaneous resection with R0 intent of intra-abdominal metastases from CRC. For patients with extra-abdominal disease, sequential resection will be permitted
Primary Outcome Measure Information:
Title
two-year disease free survival (DFS)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD, CM, MSc, FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

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Combined Resection of Colorectal Metastases

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