This trial is active, not recruiting.

Condition first line wt kras mcrc
Sponsor Dr.Laurent Mineur
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

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)
time frame: 3 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Institut Sainte Catherine.