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The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.
Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for patients with locoregional advanced head and neck cancers.
This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU) followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost one measurable lesion by RMI or CT scan.
We hope we can improve the progression free survival of 14% at two years .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug and radiation | Other | Radiotherapy : 70 grays , fractionization : 2Gy/day, 5 days / week, for 7 weeks . Concurrent administration of Carboplatin: 70 mg/m2/day (day 1 until day 4)and 5FU 600 mg/m2/day (day 1 until day 4). Weeks 1; 4; 7. |
|
| drug and radiation | Experimental | Induction chemotherapy by Docetaxel 100mg/m2, day 1; cisplatin 100mg/m2, day 1; 5-Fluorouracil 1000mg/m2 (from day 1 to day 5), for a total of three cycles .Those cycles are administrated at day 1; day 22, day43. This induction chemotherapy is followed ( for responders or stable disease patients)by radiotherapy (70 grays for 7 weeks) and concurrent Erbitux( weekly administration). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | 70 mg per m2 and per day for four days. day 1; day 22; day 43 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate of the treatment | measure of the tumor | by CT scan or MRI and endoscopy 2 years after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The second focus of this study is to compare Overall survival between the two arms . It is defined as the time from the date of randomization to the date of death from any cause. | Aftercare every six months | Date of death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lionnel GEOFFROIS, oncologist | Centre Alexis Vautrin NANCY France | Study Director |
| Etienne BARDET, oncologist | Centre Rene Gauducheau NANTES France | Principal Investigator |
| Christian SIRE, oncologist | Hopital de Bretagne Sud LORIENT France | Principal Investigator |
| Laurent MARTIN, oncologist | Centre Guillaume le Conquerant LE HAVRE France | Principal Investigator |
| Jean-Marc TOURANI, oncologist | CHU POITIERS France | Principal Investigator |
| Philippe MAINGON, oncologist | Centre Georges Francois Leclerc | Principal Investigator |
| Ayman ZAWADI, oncologist | CHD de Vendee LA ROCHE SUR YON France | Principal Investigator |
| François GUICHARD, oncologist | Polyclinique de BORDEAUX NORD France | Principal Investigator |
| Anne-Françoise DILLIES, oncologist | Centre Jean Perrin CLERMONT FERRAND France |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GIRARD CALAIS Marie-Helene | Tours | 37044 | France |
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| 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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
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| 5 fluorouracil | Drug | 600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43 |
|
| radiation therapy | Radiation | total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks |
|
| Dominique De RAUCOURT, oncologist | Centre François Baclesse CAEN France | Principal Investigator |
| Emmanuel BABIN, oncologist | Hopital Cote de Nacre CAEN France | Principal Investigator |
| Claude TUCHAIS, oncologist | Centre Paul Papin ANGERS France | Principal Investigator |
| XU SHAN Sun, oncologist | Hopital Emile Muller MULHOUSE France | Principal Investigator |
| Nicolas MEERT, oncologist | Grand Hôpital de Charleroi Belgique | Principal Investigator |
| Anne-Rose HENRY, oncologist | CHU André Vésale MONTIGNY Belgique | Principal Investigator |
| Cedrik LAFOND, oncologist | Centre Jean Bernard LE MANS France | Principal Investigator |
| Thierry PIGNON, oncologist | Centre Saint Louis TOULON France | Principal Investigator |
| Ali HASBINI, oncologist | Clinique Armoricaine SAINT BRIEUC France | Principal Investigator |
| Jean BOURHIS, oncologist | Institut Gustave Roussy VILLEJUIF France | Principal Investigator |
| Marie SALIOU, oncologist | Centre Etienne Dolet SAINT NAZAIRE France | Principal Investigator |
| Alexandre COUTTE, oncologist | CHU sud AMIENS France | Principal Investigator |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |