Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms (FCR-VADS)

Institut Bergonié

Status: Completed

Conditions: Upper Gingival Squamous Cell Carcinoma

Treatments: Drug: Cetuximab

Study type: Observational

Funder types: Other

Identifiers

NCT01827956

IB2009-24

Details and patient eligibility

About

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.

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.

Full description

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.

• 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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

121 participants in 1 patient group

UGSCS

Description:

Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment

Treatment:

Drug: Cetuximab