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The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Radiotherapy 70Gy, Erbitux, Carboplatin-5FU |
|
| 2 | Active Comparator | Radiotherapy 70Gy, Erbitux |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Drug | D-7, D1, D8, D15, D22, D29, D43, D50 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Loco-regional control | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean BOURHIS, MD, PhD | GORTEC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier Annecy | Annecy | 74000 | France | |||
| Centre Jean Perrin |
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| Carboplatin, 5FU concomitant |
| Drug |
Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46 |
|
| Radiotherapy | Radiation | 70 Gy in 7 weeks |
|
| Clermont-Ferrand |
| 63000 |
| France |
| Centre Guillaume Le Conquerant | Le Havre | 76600 | France |
| Centre hospitalier de Bretagne Sud | Lorient | 56322 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D016190 | Carboplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
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