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Spots Global Cancer Trial Database for Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal Cancer

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Trial Identification

Brief Title: Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal Cancer

Official Title: Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Standard First-line Therapy in Patients With Metastatic Colorectal Cancer

Study ID: NCT00984048

Study Description

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.

Detailed Description: The major obstacle to the cure of cancer by pharmacological agents is resistance to these agents. Clinical responses of metastatic cancers to the most advanced chemotherapeutic agents usually range from 15 to 40%, indicating that intrinsic resistance, and acquired resistance occurs almost inevitably in those tumors that do respond. In patients with metastatic colorectal cancer, clinical resistance to a particular treatment is a clear endpoint (tumor growth), and is usually observed within 6-12 months of any given therapy. Thus, drug resistance and selecting appropriate therapeutic alternatives for drug-resistant cancer remain major dilemmas for oncologists. The current first-line treatment for metastatic colorectal cancer in Quebec and much of North America is a combination called FOLFOX (the fluoro-pyrimidine 5-FU given as a 46-hour infusion, folinic acid and oxaliplatin) in combination with bevacizumab (Avastin庐). An alternative regimen of cytotoxic drugs, also used with Avastin庐, is FOLFIRI, which simply replaces oxaliplatin with the topoisomerase inhibitor irinotecan. In the metastatic setting, studies have not demonstrated significant differences between the two regimens, such that decision-making lacks definitive tools. The objective of this study is to identify, in clinical samples, the molecular signature of clinically resistant colorectal cancer (CRC) patients for the most current and commonly used therapeutic agents. The goals of this study are two-fold. First, to build a biobank of blood and tissue specimens, prior to starting chemotherapy and at a determined time-point (progression of disease), from patients undergoing the same standard and well established first-line treatments (FOLFOX/bevacizumab or FOLFIRI/bevacizumab) for metastatic colorectal cancer. Second, to use state-of-the-art approaches by various collaborating laboratories to correlate clinical outcomes with molecular events that can be used to predict and circumscribe chemoresistance.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University Hospital Leuven, Leuven, , Belgium

The Moncton Hospital, Moncton, New Brunswick, Canada

Dr. Georges L. Dumont University Hospital, Moncton, New Brunswick, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Mount Sinai Hospital, Toronto, Ontario, Canada

H么pital Charles Lemoyne, Greenfield Park, Quebec, Canada

H么pital Maisonneuve-Rosemont, Montreal, Quebec, Canada

H么pital Notre-Dame, Montreal, Quebec, Canada

H么pital Saint-Luc, Montreal, Quebec, Canada

Royal Victoria Hospital, Montreal, Quebec, Canada

Jewish General Hospital, Montreal, Quebec, Canada

St-Mary's Hospital, Montreal, Quebec, Canada

McGill University Health Centre, Montreal, Quebec, Canada

H么pital Sacr茅-Coeur, Montreal, Quebec, Canada

H么tel-Dieu du Qu茅bec, Qu茅bec, Quebec, Canada

Contact Details

Name: Gerald Batist, MD

Affiliation: Jewish General Hospital, Segal Cancer Center

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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