NCT01827956

Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 121 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. * 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

• Upper Gingival Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cetuximab	Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-08-01
• Completion: 2013-12-01
• First posted: 2013-04-10
• Last updated: 2025-12-29
• Results posted: 2025-12-29

Locations

1 site across 1 country: France