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Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms (FCRVADS)

Primary Purpose

Upper Gingival Squamous Cell Carcinoma

Status
Completed
Phase
Locations
France
Study Type
Observational
Intervention
Blood sample for identifying the polymorphism
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Upper Gingival Squamous Cell Carcinoma focused on measuring Upper aero-digestive tract tumours, FCGR3A and FCGR2A receptor polymorphism, Cetuximab efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Bergonié

Arms of the Study

Arm 1

Arm Type

Arm Label

Blood sample

Arm Description

Blood sample for identifying the polymorphism

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2012
Last Updated
April 9, 2013
Sponsor
Institut Bergonié
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1. Study Identification

Unique Protocol Identification Number
NCT01827956
Brief Title
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms
Acronym
FCRVADS
Official Title
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours
Study Type
Observational

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gingival Squamous Cell Carcinoma
Keywords
Upper aero-digestive tract tumours, FCGR3A and FCGR2A receptor polymorphism, Cetuximab efficacy

7. Study Design

Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood sample
Arm Description
Blood sample for identifying the polymorphism
Intervention Type
Other
Intervention Name(s)
Blood sample for identifying the polymorphism
Intervention Description
Blood sample for identifying the polymorphism
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Proportion of patients with positive response to treatment at 4 months
Secondary Outcome Measure Information:
Title
Progression-free survival Overall survival Toxicity
Description
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
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Study Population Description
Squamous cell carcinomas of the upper aero-digestive tract recurrent or metastatic.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROBERT Jacques, PU-PH
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms

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