N/A
Completed N=121
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms
Upper Gingival Squamous Cell Carcinoma
Source: ClinicalTrials.gov NCT01827956 ↗
Enrolled (actual)
121
Serious AEs
—
Results posted
Dec 2025
Primary outcomePrimary: Polymorphism of FCGR2 Gene — 29; 53; 36 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Polymorphism of FCGR2 Gene |
29; 53; 36 | — |
| PRIMARY Polymorphism of FCGR3A Gene |
54; 48; 15 | — |
| SECONDARY 4-month Non-progression Rate According to the Polymorphism |
18; 47; 23; 30 | — |
| SECONDARY Overall Survival Rate |
10.16; 10.48 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01827956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.