PREMIUM, Observational Study
This trial is active, not recruiting.
|Condition||first line wt kras mcrc|
|Collaborator||Merck Serono International SA|
|Start date||January 2010|
|End date||March 2012|
|Trial size||500 participants|
|Trial identifier||NCT01756625, PREMIUM|
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.
To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
time frame: 3 years
ORR at 1 year (ITT and subgroup analysis)
time frame: 3 years
Male or female participants at least 18 years old.
Inclusion Criteria: - patients > 18 years old diagnosed with mCRC - patients naïve for CT excepted for adjuvant setting or trated max 2 cycles CT in first line mCRC with or without cetuximab - all patients receiving cetuximab in first line treatment associated or not with CT - patients relapsed < 6 months after an adjuvant therapy Exclusion Criteria: - patients participating to clinical trials
|Official title||Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer|
|Description||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.|
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