Trial Outcomes & Findings for Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms (NCT NCT01827956)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

121 participants

Primary outcome timeframe

At treatment initiation

Results posted on

2025-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	UGSCS Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
Overall Study STARTED	121
Overall Study COMPLETED	118
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	UGSCS Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
Overall Study Protocol Violation	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UGSCS n=121 Participants Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
Age, Continuous	60.9 years n=121 Participants
Sex: Female, Male Female	25 Participants n=121 Participants
Sex: Female, Male Male	96 Participants n=121 Participants
Region of Enrollment France	121 participants n=121 Participants

PRIMARY outcome

Timeframe: At treatment initiation

Population: Population with FCGR2 gene contributive results

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.

Outcome measures

Outcome measures
Measure	UGSCS n=118 Participants Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes	UGSCS With Polymorphism Other Than "FCG2RA = HH or FCG3RA = VV" Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
Polymorphism of FCGR2 Gene RR	29 Participants	—
Polymorphism of FCGR2 Gene RH	53 Participants	—
Polymorphism of FCGR2 Gene HH	36 Participants	—

PRIMARY outcome

Timeframe: At treatment initiation

Population: Population with FCGR3 gene contributive results

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.

Outcome measures

Outcome measures
Measure	UGSCS n=117 Participants Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes	UGSCS With Polymorphism Other Than "FCG2RA = HH or FCG3RA = VV" Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
Polymorphism of FCGR3A Gene FF	54 Participants	—
Polymorphism of FCGR3A Gene FV	48 Participants	—
Polymorphism of FCGR3A Gene HH	15 Participants	—

SECONDARY outcome

Timeframe: 4 months after treatment initiation

Population: Population with either FCGR2 gene contributive results or FCGR3 gene contributive results

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.

Outcome measures

Outcome measures
Measure	UGSCS n=41 Participants Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes	UGSCS With Polymorphism Other Than "FCG2RA = HH or FCG3RA = VV" n=77 Participants Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
4-month Non-progression Rate According to the Polymorphism Non progression	18 Participants	47 Participants
4-month Non-progression Rate According to the Polymorphism Progression	23 Participants	30 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Population with either FCGR2 gene contributive results and FCGR3 gene contributive results and follow-up data available

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

Outcome measures

Outcome measures
Measure	UGSCS n=41 Participants Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes	UGSCS With Polymorphism Other Than "FCG2RA = HH or FCG3RA = VV" n=77 Participants Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes
Overall Survival Rate	10.16 months Interval 6.57 to 15.25	10.48 months Interval 6.97 to 14.0

Adverse Events

UGSCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 87 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Simone Mathoulin-Pélissier, Director of Clinical Trials Unit

Institut Bergonié

Phone: +33556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place