Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms

Completed

• Conditions: Upper Gingival Squamous Cell Carcinoma

• Registration Number: NCT01827956
• Lead Sponsor: Institut Bergonié

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.

Detailed 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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2012-11-05
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-10
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Proportion of patients with positive response to treatment at 4 months	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

Secondary Outcome Measures

Name	Time	Method
Progression-free survival Overall survival Toxicity	Progression-free survival: Tumour evaluation will be done at baseline and at 4 months or until the earlier of the following events: disease progression, patient death.	Overall survival: defined as the time between the first cycle of chemotherapy and the date of death, all causes. In the absence of death confirmation, survival data are censored from the date of last news

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, Aquitaine, France