Upper Gingival Squamous Cell Carcinoma Clinical Trial
— FCRVADSOfficial title:
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours
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.
| Status | Completed |
| Enrollment | 121 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
N/A
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Bergonié | Bordeaux | Aquitaine |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Bergonié |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | No |
| Secondary | Progression-free survival Overall survival Toxicity | 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 | 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. | Yes |