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Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours


N/A
18 Years
N/A
Not Enrolling
Both
Upper Gingival Squamous Cell Carcinoma

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Trial Information

Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours


Hypothesis:

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.


Inclusion Criteria:



- Patient with recurrent or metastatic squamous cell carcinomas of the upper
aero-digestive tract

- 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:

- Pregnancy

- 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

The main objective is to evaluate the role of FCGR3A and FCGR2A receptor polymorphism in cetuximab and chemotherapy response, in patients with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract

Outcome Description:

The main objective is to evaluate the role of FCGR3A and FCGR2A receptor polymorphism in cetuximab and chemotherapy response, in patients with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract

Outcome Time Frame:

Proportion of patients with positive response to treatment at 4 months

Safety Issue:

No

Principal Investigator

ROBERT Jacques, PU-PH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Bergonié

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IB2009-24

NCT ID:

NCT01827956

Start Date:

October 2009

Completion Date:

June 2011

Related Keywords:

  • Upper Gingival Squamous Cell Carcinoma
  • Upper aero-digestive tract tumours
  • FCGR3A and FCGR2A receptor polymorphism
  • Cetuximab efficacy
  • Carcinoma
  • Carcinoma, Squamous Cell

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