Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
18 Years
N/A
Both
Colorectal Cancer
Trial Information
Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
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),
radiofrequence 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
two-year disease free survival (DFS)
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Alice Wei, MD, CM, MSc, FRCSC
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Toronto
Authority:
Canada: Ethics Review Committee
Study ID:
GIAW1
NCT ID:
NCT00606398
Start Date:
June 2007
Completion Date:
Related Keywords:
- Colorectal Cancer
- colorectal metastases
- Colorectal Neoplasms
- Neoplasm Metastasis
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