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PREMIUM, Observational Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Serono International SA
BESPIM, CHU Nîmes (data analysis)
Information provided by (Responsible Party):
Dr.Laurent Mineur, Institut Sainte Catherine
ClinicalTrials.gov Identifier:
NCT01756625
First received: December 20, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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
First Line WT KRAS mCRC

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by Institut Sainte Catherine:

Primary Outcome Measures:
  • To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ORR at 1 year (ITT and subgroup analysis) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients from private and public centers

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756625

Locations
France
Institut Sainte-Catherine
Avignon, Vaucluse, France, 84000
Sponsors and Collaborators
Dr.Laurent Mineur
Merck Serono International SA
BESPIM, CHU Nîmes (data analysis)
  More Information

No publications provided

Responsible Party: Dr.Laurent Mineur, Oncologist, Institut Sainte Catherine
ClinicalTrials.gov Identifier: NCT01756625     History of Changes
Other Study ID Numbers: PREMIUM
Study First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: France : CCTIRS / CNIL

Keywords provided by Institut Sainte Catherine:
cetuximab
nicotine
magnesium

ClinicalTrials.gov processed this record on May 23, 2013