Official Title
Comprehensive Genomic Profiling of Colorectal Cancer Patients With Isolated Liver Metastases to Understand Response & Resistance to Cancer Therapy
Brief Title
Comprehensive Genomic Profiling of Colorectal Cancer Patients With Isolated Liver Metastases to Understand Response & Resistance to Cancer Therapy
Protocol ID
NCT03364621
Lead Sponsor
University Health Network, Toronto
Brief Summary
This is a prospective study investigating the disease course of patients with colorectal
cancer that have had their cancer spread to their liver. The aim of this study is find
potential biomarkers for disease recurrence and therapeutic targets for prognostic
information.
Detailed Description
Colorectal cancer (CRC), the 2nd leading cause of cancer mortality, often has a pattern
of targeting the liver during initial metastases. The Comprehensive Genomic Profiling of
Colorectal Cancer Patients with Isolated Liver Metastases to Understand Response and
Resistance to Cancer Therapy (COMPARISON) study aims to assess the disease course of CRC
by collecting primary tumor and metastatic liver specimens following pre-operative
chemotherapy. If relapse occurs following surgical resection of the liver, biopsies will
also be done for molecular analysis. As a result, these samples can be analyzed for
chemotherapy resistance mechanisms and therapeutic targets to determine potential
clinical outcomes for this particular subset of CRC patients.
Study Period
-
Enrollment Count
17 participants
Eligibility Criteria
Eligibility Criteria:
1. Patients must have histologically confirmed CRC with isolated liver metastasis
2. Patients must be planned for a hepatic metastasectomy
3. Patients must have received at least 3 cycles of chemotherapy (FOLFOX or FOLFIRI
with or without Bevacizumab) prior to the planned hepatic metastasectomy
4. Primary tumor must be considered resectable with a plan for this to either occur
concurrently with the liver resection or subsequent to this.
5. If primary has already been resected before liver resection, archival tissue must be
available for genomic analysis
6. Patients must be 18yrs of age or older
7. Ability to understand and willing to sign a written informed consent document
Exclusion Criteria:
1. Patients with un-resectable or borderline resectable isolated liver metastases as
judged by the multidisciplinary hepatobiliary tumor board at PM or BCCA after a
course of pre-operative chemotherapy will be excluded
2. Patients with evidence of possible metastatic disease at any sites outside the liver
are not eligible
3. Patients with any major co-morbidity or co-morbidities that will render liver
resection very high risk in investigator's opinion
4. Any other condition that would, in the Investigator's judgment, contraindicate the
patient's participation in the clinical study due to safety concerns or compliance
with clinical study procedures.
5. Patients with a previous history of another primary cancer treated within 5 years of
study entry are not eligible except those with basal cell or squamous cell carcinoma
of the skin and intraepithelial neoplasia.
Filters
Colorectal Cancer
Colorectal Cancer Metastatic
Hepatic Metastases
ACTIVE_NOT_RECRUITING
ADULT
OLDER_ADULT