Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms

NCT01827956 | Completed Results

• 1 other identifier: IB2009-24
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Gingival Squamous Cell Carcinoma

Keywords

Upper aero-digestive tract tumours; FCGR3A and FCGR2A receptor polymorphism; Cetuximab efficacy

Outcome Measures

Primary Outcomes (2)

• Polymorphism of FCGR2 Gene

  Polymorphism of FCGR2A gene is expressed according to 3 modalities : RR / RH / HH Genomic DNA will be extracted from whole blood tubes and redissolved in 100 µl 1× TE buffer and purified on GFX columns (Amersham-Biosciences). The quantity and quality of the DNA will be checked by agarose gel electrophoresis in the presence of ethidium bromide. Polymorphisms will be detected by PCR followed by pyrosequencing.

  At treatment initiation

• Polymorphism of FCGR3A Gene

  Polymorphism of FCGR3A gene is expressed according to 3 modalities : FF / FV / VV. Genomic DNA will be extracted from whole blood tubes and redissolved in 100 µl 1× TE buffer and purified on GFX columns (Amersham-Biosciences). The quantity and quality of the DNA will be checked by agarose gel electrophoresis in the presence of ethidium bromide. Polymorphisms will be detected by PCR followed by pyrosequencing.

  At treatment initiation

Secondary Outcomes (2)

• 4-month Non-progression Rate According to the Polymorphism

  4 months after treatment initiation

• Overall Survival Rate

  12 months

Study Arms (1)

UGSCS

Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment

Drug: Cetuximab

Interventions

Cetuximab DRUG

Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes

UGSCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Squamous cell carcinomas of the upper aero-digestive tract recurrent or metastatic.

You may qualify if:

• Patient with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract
• Patient with loco-regional extension not readily treatable
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Location

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
• Organization: Institut Bergonié

s.mathoulin@bordeaux.unicancer.fr

+33556333333

Study Officials

• ROBERT Jacques, PU-PH

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: April 10, 2013
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2013
• Last Updated: December 29, 2025
• Results First Posted: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)