Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal Cancer
Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Standard First-line Therapy in Patients With Metastatic Colorectal Cancer
1 other identifier
observational
160
2 countries
15
Brief Summary
This is a multicenter translational study to understand therapeutic resistance in patients undergoing first-line chemotherapy (FOLFOX/Avastin, or FOLFIRI/Avastin) for metastatic colorectal cancer. Tissue samples from liver metastasis will be collected and banked before the start of chemotherapy and at the time of progression. Additionally, blood samples will be drawn monthly and stored in the tissue biobank.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2009
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 23, 2009
CompletedFirst Posted
Study publicly available on registry
September 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedJune 15, 2021
June 1, 2021
10 years
September 23, 2009
June 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in biomarkers in patients that have acquired clinical resistance.
Liver needle core biopsies are obtained pre-treatment and at progression of disease from all patients. These are used to discover exploratory biomarkers of resistance to FOLFOX/bevacizumab and FOLFIRI/bevacizumab
4 years
Secondary Outcomes (1)
Number of participants with adverse events relating to the liver biopsy procedure
3 years
Study Arms (1)
FOLFOX, XELOX or FOLFIRI +/- bevacizumab
Patients are scheduled to receive first-line treatment for metastatic disease. They should be receiving at least one component of either FOLFOX, XELOX or FOLFIRI regimen with or without bevacizumab.
Interventions
No investigational products will be administered to subjects as part of this translational research study. A first-line chemotherapy regimen consisting of FOLFOX, XELOX or FOLFIRI +/- bevacizumab will be administered as per the standard of care at each treating institution. Needle core biopsies of liver metastasis will be collected and banked before the start of chemotherapy and at the time of progression. Additionally, blood samples will be drawn monthly and stored in the tissue biobank.
Eligibility Criteria
This study will be conducted in patients with a confirmed diagnosis of colorectal cancer with the presence of liver metastasis, who will be receiving first-line treatment (FOLFOX/bevacizumab or FOLFIRI/bevacizumab) for metastatic disease.
You may qualify if:
- Patients with a histologically confirmed diagnosis of colorectal cancer, with at least one liver metastasis site available for biopsy.
- For patients with liver only disease, patients deemed not to be initially resectable
- Scheduled to receive first-line chemotherapy (FOLFOX/bevacizumab or FOLFIRI/bevacizumab) for metastatic disease.
- Measurable metastatic disease (at least one unidimensionally measurable lesion) present after planned biopsy of metastatic site(s).
- ECOG 0, 1 or 2.
- Life expectancy of 12 or more weeks.
- Age \> 18 years.
- Able to adhere to the study visit schedule and other protocol requirements.
- Normal coagulation profile (PT, PTT, INR).
You may not qualify if:
- Patients with initially resectable liver only metastases
- Have received prior therapy for metastatic cancer. Prior adjuvant therapy is allowed.
- Inadequate or unusable tissue as the only tissue available for biopsy.
- Contraindication to any of the components of the the first-line chemotherapy regimen.
- Known brain metastases or meningeal disease.
- Female patients who are pregnant or breastfeeding.
- Concurrent treatment with other anti-cancer therapy (palliative radiation is allowed but patients must have a metastatic site available for re-biopsy that has not been irradiated).
- Abnormal coagulation profile, any anti-coagulant therapy.
- Known infection with HIV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jewish General Hospitallead
- Exactis Innovationcollaborator
- Terry Fox Research Institutecollaborator
- Fonds de la Recherche en Santé du Québeccollaborator
Study Sites (15)
University Hospital Leuven
Leuven, Belgium
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Dr. Georges L. Dumont University Hospital
Moncton, New Brunswick, E1C 8X3, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Hôpital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
St-Mary's Hospital
Montreal, Quebec, H3T 1M5, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Hôpital Sacré-Coeur
Montreal, Quebec, Canada
Hôtel-Dieu du Québec
Québec, Quebec, G1R 2J6, Canada
Biospecimen
Tumor tissue from a hepatic metastasis will be removed by needle core biopsy (NCB) obtained under radiologic guidance and will be flash-frozen. To obtain sufficient material for tissue banking, three needle core biopsies (NCB) will be removed from the same metastasis. Additionally, monthly whole blood samples will be collected, as well as plasma.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gerald Batist, MD
Jewish General Hospital, Segal Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 23, 2009
First Posted
September 24, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
June 15, 2021
Record last verified: 2021-06