Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
18 Years
N/A
Both
First Line WT KRAS mCRC
Trial Information
Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
Outcome Time Frame:
3 years
Safety Issue:
No
Authority:
France : CCTIRS / CNIL
Study ID:
PREMIUM
NCT ID:
NCT01756625
Start Date:
January 2010
Completion Date:
June 2013
Related Keywords:
- First Line WT KRAS mCRC
- cetuximab
- nicotine
- magnesium
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