Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms
- Conditions
- Upper Gingival Squamous Cell Carcinoma
- Interventions
- Other: Blood sample for identifying the polymorphism
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- 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
- 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
- Arm && Interventions
Group Intervention Description Blood sample Blood sample for identifying the polymorphism Blood sample for identifying the polymorphism
- 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