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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UGSCS | Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Squamous cell carcinomas of the upper aero-digestive tract recurrent or metastatic.
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| Name | Affiliation | Role |
|---|---|---|
| ROBERT Jacques, PU-PH | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | Aquitaine | 33000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | UGSCS | Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | UGSCS | Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Population with FCGR2 gene contributive results | Posted | Count of Participants | Participants | At treatment initiation |
|
24 months
Serious Adverse Events and other NON Serious Adverse Events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UGSCS | Patients with Upper Gingival Squamous Cell Carcinoma initiating Cetuximab treatment Cetuximab: Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials Unit | Institut Bergonié | +33556333333 | s.mathoulin@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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 | 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Population with FCGR3 gene contributive results | Posted | Count of Participants | Participants | At treatment initiation |
|
|
|
| Secondary | 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. | Population with either FCGR2 gene contributive results or FCGR3 gene contributive results | Posted | Count of Participants | Participants | 4 months after treatment initiation |
|
|
|
| Secondary | 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 | Population with either FCGR2 gene contributive results and FCGR3 gene contributive results and follow-up data available | Posted | Median | 95% Confidence Interval | months | 12 months |
|
|
|
| 87 |
| 121 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |