First Line WT KRAS mCRC
Conditions
Keywords
cetuximab, nicotine, magnesium
Brief summary
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.
Detailed 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.
Interventions
None listed
Sponsors
Merck Serono International SA
BESPIM, CHU Nîmes (data analysis)
Dr.Laurent Mineur
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis) | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| ORR at 1 year (ITT and subgroup analysis) | 3 years |
Countries
France
Outcome results
None listed