Upper Gingival Squamous Cell CarcinomaFCR-VADSNCT01827956
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms
An observational study of Upper Gingival Squamous Cell Carcinoma, run by Institut Bergonié at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gingival Squamous Cell Carcinoma
- What is being tested?
- Cetuximab
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Squamous cell carcinomas of the upper aero-digestive tract recurrent or metastatic.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the 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
- Being tested
- Cetuximab
- Keywords
- Upper aero-digestive tract tumours, FCGR3A and FCGR2A receptor polymorphism, Cetuximab efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
| Study group | Role | What they receive |
|---|---|---|
| UGSCS | Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphism of FCGR2 Gene
Polymorphism of FCGR2A gene is expressed according to 3 modalities : RR / RH / HH
Genomic DNA will be extracted from whole blood tubes and redissolved in 100 µl 1× TE buffer and purified on GFX columns (Amersham-Biosciences). The quantity and quality of the DNA will be checked by agarose gel electrophoresis in the presence of ethidium bromide. Polymorphisms will be detected by PCR followed by pyrosequencing.
Measured: At treatment initiation
Polymorphism of FCGR3A Gene
Polymorphism of FCGR3A gene is expressed according to 3 modalities : FF / FV / VV.
Genomic DNA will be extracted from whole blood tubes and redissolved in 100 µl 1× TE buffer and purified on GFX columns (Amersham-Biosciences). The quantity and quality of the DNA will be checked by agarose gel electrophoresis in the presence of ethidium bromide. Polymorphisms will be detected by PCR followed by pyrosequencing.
Measured: At treatment initiation
Secondary outcomes (2)
4-month Non-progression Rate According to the Polymorphism
The primary endpoint is the 4-month non-progression rate assessed according to RECIST criteria (or according to a clinical assessment if the patient does not undergo radiological examination). The response will be considered "no progression" in the following cases: complete response, partial response, or stable disease. In other cases (disease progression or unevaluable), the disease will be considered to be progressing.
Response will be assessed at enrollment and at 4 months or until the first of the following events: disease progression or patient death.
Measured: 4 months after treatment initiation
Overall Survival Rate
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startAug 2009
- Primary completionAug 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Gingival Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROBERT Jacques, PU-PH, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827956
- Sponsor's protocol ID
- IB2009-24
- Acronym
- FCR-VADS
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2012
- Last updated
- 29 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours
- ClinicalTrials.gov ID
- NCT01827956
- Acronym / sponsor ID
- FCR-VADS / IB2009-24
- Conditions
- Upper Gingival Squamous Cell Carcinoma
- Keywords
- Upper aero-digestive tract tumours, FCGR3A and FCGR2A receptor polymorphism, Cetuximab efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Posted 29 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UGSCS | – | Drug: CetuximabPatients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Squamous cell carcinomas of the upper aero-digestive tract recurrent or metastatic.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabBlood sample for identifying the polymorphism of FCGR3A and FCGR2A genes | Drug | UGSCS |
Primary outcome
Polymorphism of FCGR2 Gene
Time frame: At treatment initiation
Polymorphism of FCGR2A gene is expressed according to 3 modalities : RR / RH / HH Genomic DNA will be extracted from whole blood tubes and redissolved in 100 µl 1× TE buffer and purified on GFX columns (Amersham-Biosciences). The quantity and quality of the DNA will be checked by agarose gel electrophoresis in the presence of ethidium bromide. Polymorphisms will be detected by PCR followed by pyrosequencing.
Polymorphism of FCGR3A Gene
Time frame: At treatment initiation
Polymorphism of FCGR3A gene is expressed according to 3 modalities : FF / FV / VV. Genomic DNA will be extracted from whole blood tubes and redissolved in 100 µl 1× TE buffer and purified on GFX columns (Amersham-Biosciences). The quantity and quality of the DNA will be checked by agarose gel electrophoresis in the presence of ethidium bromide. Polymorphisms will be detected by PCR followed by pyrosequencing.
2 secondary outcomes
4-month Non-progression Rate According to the Polymorphism
Time frame: 4 months after treatment initiation
Overall Survival Rate
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROBERT Jacques, PU-PH principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gingival Squamous Cell Carcinoma, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polymorphism of FCGR2 Gene (time frame: At treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.