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ClinicalTrials.gov Identifier: NCT01756625
Verified December 2012 by Dr.Laurent Mineur, Institut Sainte Catherine. Recruitment status was: Active, not recruiting
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.
Condition or disease
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients from private and public centers
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