PREMIUM, Observational Study

Dr.Laurent Mineur500 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

First Line WT KRAS mCRC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Sainte-Catherine

Avignon, Vaucluse, France

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)

Time frame: 3 years

Data from ClinicalTrials.gov

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