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PREMIUM, Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756625
Recruitment Status : Unknown
Verified December 2012 by Dr.Laurent Mineur, Institut Sainte Catherine.
Recruitment status was:  Active, not recruiting
First Posted : December 27, 2012
Last Update Posted : December 27, 2012
Merck Serono International SA
BESPIM, CHU Nîmes (data analysis)
Information provided by (Responsible Party):
Dr.Laurent Mineur, Institut Sainte Catherine

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.

Condition or disease
First Line WT KRAS mCRC

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.

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
Study Start Date : January 2010
Actual Primary Completion Date : March 2012
Estimated Study Completion Date : June 2013

First line WT KRAS mCRC

Primary Outcome Measures :
  1. To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. ORR at 1 year (ITT and subgroup analysis) [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients from private and public centers

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756625

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Institut Sainte-Catherine
Avignon, Vaucluse, France, 84000
Sponsors and Collaborators
Dr.Laurent Mineur
Merck Serono International SA
BESPIM, CHU Nîmes (data analysis)
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Responsible Party: Dr.Laurent Mineur, Oncologist, Institut Sainte Catherine Identifier: NCT01756625    
Other Study ID Numbers: PREMIUM
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012
Keywords provided by Dr.Laurent Mineur, Institut Sainte Catherine: