Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
Time Frame: 3 years
Secondary Outcomes
- ORR at 1 year (ITT and subgroup analysis)(3 years)
Investigators
Dr.Laurent Mineur
Oncologist
Institut Sainte Catherine