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PREMIUM, Observational Study

NCT ID: NCT01756625

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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First Line WT KRAS mCRC

Keywords

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cetuximab nicotine magnesium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First line WT KRAS mCRC

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono International SA

INDUSTRY

Sponsor Role collaborator

BESPIM, CHU Nîmes (data analysis)

UNKNOWN

Sponsor Role collaborator

Dr.Laurent Mineur

OTHER

Sponsor Role lead

Responsible Party

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Dr.Laurent Mineur

Oncologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Institut Sainte-Catherine

Avignon, Vaucluse, France

Site Status

Countries

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France

References

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Mineur L, Francois E, Plassot C, Phelip JM, Miglianico L, Dourthe LM, Bonichon N, Moreau L, Guimbaud R, Smith D, Achille E, Herve R, Bons JM, Remy S, Faroux R, Villing AL, Mahamat A, Rabbia I, Soulie P, Baumgaertner I, Mathe N, Vazquez L, Boustany R. PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer. PLoS One. 2020 Dec 21;15(12):e0243997. doi: 10.1371/journal.pone.0243997. eCollection 2020.

Reference Type DERIVED
PMID: 33347495 (View on PubMed)

Other Identifiers

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PREMIUM

Identifier Type: -

Identifier Source: org_study_id