PREMIUM, Observational Study

Dr.Laurent Mineur

Status: Unknown

Conditions: First Line WT KRAS mCRC

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01756625

PREMIUM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

First line WT KRAS mCRC