PREMIUM, Observational Study

First Line WT KRAS mCRC Clinical Trial

Official title:

Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01756625
• Other study ID #: PREMIUM
• Status: Active, not recruiting
• Phase: N/A
• First received: December 20, 2012
• Last updated: December 20, 2012
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: December 2012
• Source: Institut Sainte Catherine
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : CCTIRS / CNIL
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• First Line WT KRAS mCRC

Locations

Country	Name	City	State
France	Institut Sainte-Catherine	Avignon	Vaucluse

Sponsors (3)

Lead Sponsor	Collaborator
Dr.Laurent Mineur	BESPIM, CHU Nîmes (data analysis), Merck Serono International SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)		3 years	No
Secondary	ORR at 1 year (ITT and subgroup analysis)		3 years	No