Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
121 participants
OBSERVATIONAL
2009-08-31
2013-12-31
Brief Summary
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Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.
The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.
Detailed Description
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Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.
We therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.
This study is a multicentre prospective pharmacogenetic observational study, conducted on locally advanced and inoperable upper aerodigestive tract cancers.
* Blood sample for polymorphism identification (5 ml plastic tube with EDTA, taken at the start of treatment, at the same time as the blood samples routinely taken as part of standard care)
* Collection of medical data at inclusion and at 4 months
Conditions
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Keywords
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Study Design
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OTHER
OTHER
Study Groups
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UGSCS
Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment
Cetuximab
Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
Interventions
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Cetuximab
Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
Eligibility Criteria
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Inclusion Criteria
* Patient with loco-regional extension not readily treatable
* 18 years
* Follow up in participant center
* Patient information and consent for study participation
* Patient presented in multidisciplinary meeting (RCP) in Aquitaine and for whom a treatment containing cetuximab has been proposed
* Belong to a social security system
Exclusion Criteria
* Patient with psychological, social, family or geographical reason, who could not be treated or monitored regularly by study criteria,
* Patients deprived of liberty or under guardianship or who could not give consent for study participation
* Inclusion in another study
18 Years
ALL
No
Sponsors
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Institut Bergonié
OTHER
Responsible Party
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Principal Investigators
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ROBERT Jacques, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Institut Bergonié
Locations
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Institut Bergonié
Bordeaux, Aquitaine, France
Countries
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Other Identifiers
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IB2009-24
Identifier Type: -
Identifier Source: org_study_id