PREMIUM, Observational Study
PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.
First Line WT KRAS mCRC
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer|
- To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- ORR at 1 year (ITT and subgroup analysis) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|First line WT KRAS mCRC|
Retrospective studies have shown the influence of some factors on the efficacy of treatment with cetuximab (nicotine, magnesium etc..). No randomized study has compared the mode of administration of weekly and biweekly cetuximab. What are the factors influencing patient compliance? Adverse events, the relation between doctor and patient. PREMIUM will attempt to explore and assess the variables associated with efficacy and compliance to treatment and study practices in France for clinical management.