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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB:2011-A01174-37 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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In France, the incidence of head and neck squamous cell carcinomas (HNSCC) is 16 000 new cases/year. During these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients notably anti-HER molecules. In inoperable recurrent and/or metastatic HNSCC, the best treatment is based on an anti-Human Epidermal Growth Factor Receptor (EGFR) antibody, targeting Human Epidermal Growth Factor Receptor 1 (HER1), the Cetuximab combined with platinum +/- 5 Fluoro Uracil (5FU): " Extreme protocol ". However, no clinical or biological criteria predictive of drug efficacy have been reported yet. Thus, the development of such a predictive factor is an urgent need in HNSCC at both the clinical and pharmacy-economic level, to propose the best personalized treatment. One idea would be to enumerate and characterize the circulating tumor cells (CTC) which could give us an early evaluation of the therapeutic efficiency. In this context, the investigators have developed an innovative technology, the EPISPOT assay (patent of the University Medical Center of Montpellier), that allows the detection & characterization of viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the breast and prostate cancer.Thus, the investigators would like for the first time to perform a prospective study on a cohort of patients treated following the Extreme protocol, with this technology, to assess the predictive value of CTC count. The investigators will use the CellSearch® system as the reference test.
This is a multi-centric prospective non randomized open labeled study performed on a cohort of patients with inoperable recurrent and/or metastatic HNSCC who will be treated, with a first line treatment based on an anti-Human Epidermal Growth Factor Receptor (HER), the Cetuximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTC assay, Cetuximab | Other | Detection & characterization of viable CTC in the peripheral blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood analysis by EPISPOT and CellSearch® | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Predictive value of the CTC on the Progression Free Survival | The primary outcome aims to evaluate the predictive value of the early progression of the CTC performed with the EPISPOT assay on the progression free survival in a cohort of patients treated with protocol "Extreme". The progression disease is assessed based on imagery techniques. | Duration study 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic value of the CTC at baseline (EPISPOT) and to compare for the first time the results with those obtained with the CellSearch system. | Duration study 2 years | |
| Prognostic value of the CTC at baseline (EPISPOT) | Duration study 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Alix Panabieres, PhD | Contact | +33467330305 | c-panabieres@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| RENAUD GARREL, MD | CHU GUI DE CHAULIAC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, CHU Gui de Chauliac | Recruiting | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31387885 | Derived | Garrel R, Mazel M, Perriard F, Vinches M, Cayrefourcq L, Guigay J, Digue L, Aubry K, Alfonsi M, Delord JP, Lallemant B, Even C, Daures JP, Landais P, Cupissol D, Alix-Panabieres C. Circulating Tumor Cells as a Prognostic Factor in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: The CIRCUTEC Prospective Study. Clin Chem. 2019 Oct;65(10):1267-1275. doi: 10.1373/clinchem.2019.305904. Epub 2019 Aug 6. | |
| 30811063 |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Predictive value of the early progression of CTC (EPISPOT) on the overall survival | Duration study 2 years |
| Compare for the first time the results with those obtained with the CellSearch® system | Duration study 2 years |
| Evaluate the expression of EGFR in CTCs before and after administration of cetuximab (Erbitux) with both technologies and EPISPOT CellSearch ® | Duration study 2 years |
| Evaluate the impact of the presence of epithelial-mesenchymal transition (EMT) marker on the prognosis | Duration study 2 years |
| Derived |
| Le Louedec F, Alix-Panabieres C, Lafont T, Allal BC, Garrel R, Digue L, Guigay J, Cupissol D, Delord JP, Lallemant B, Alfonsi M, Aubry K, Mazel M, Becher F, Perriard F, Chatelut E, Thomas F. Cetuximab pharmacokinetic/pharmacodynamics relationships in advanced head and neck carcinoma patients. Br J Clin Pharmacol. 2019 Jun;85(6):1357-1366. doi: 10.1111/bcp.13907. Epub 2019 Apr 13. |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |