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The purpose of this study is to investigate in patients with cancer of the throat and recurrent inoperable a different modality treatment consisting of radiation continuously for 5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer, called Erbitux ®.
The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment) to improve the antitumor efficacy without additional toxic side effects.
We hope with this treatment improved antitumor efficacy without additional toxic side effects, while being shorter than 1.5 weeks of standard therapy. But this is an hypothesis we can not meet the current state of knowledge, which justifies this study.
The main hypothesis is that this combination of reirradiation and Cetuximab give a relative gain of 15% complete response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erbitux Radiotherapy | Other | Radiotherapy during 5 weeks and concurrent Erbitux once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erbitux | Drug | To begin 7 days before radiotherapy, loading dose 400 mg / m² in the first week then 250 mg / m² weekly for the duration of radiotherapy (for a total of 7 doses including the loading dose) |
| Measure | Description | Time Frame |
|---|---|---|
| The main objective is to evaluate the complete response rate of the association re-irradiation - Erbitux ®. | It will be measured by spiral CT scan or magnetic resonance imaging (MRI), 2 months after the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent MARTIN, oncologist | Centre Guillaume Le Conquérant, 76600 Le Havre, France | Study Director |
| Claude TUCHAIS, oncologist | Centre Paul Papin, 49933 Angers, France | Principal Investigator |
| Sauveur Marc ALFONSI, oncologist | Institut Sainte Catherine, 84082 Avignon, France | Principal Investigator |
| Xu Sh SUN, oncologist | Hôpital Jean Minoz, 25030 Besançon, France | Principal Investigator |
| Dominique DE RAUCOURT, oncologist | Centre François Baclesse, 14076 Caen, France | Principal Investigator |
| Michel LAPEYRE, oncologist | Centre Jean Perrin, 63011 Clermond-Ferrand, France | Principal Investigator |
| Philippe MAINGON, oncologist | Centre G-F Leclerc, 21079 Dijon, France | Principal Investigator |
| Muriel GARCIA-RAMIREZ, oncologist | Hôpital Robert Boulin, 33505 Libourne, France | Principal Investigator |
| Christian SIRE, oncologist | Hôpital du Scorff, 56322 Lorient, France |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Bretonneau | 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 |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Principal Investigator |
| Séverine RACADOT, oncologist | Centre Léon Bérard, 69373 Lyon, France | Principal Investigator |
| Véronique FAVREL, oncologist | Centre Hospitalier Lyon Sud, 69495 Pierre-Benite, France | Principal Investigator |
| Etienne BARDET, oncologist | Centre René Gauducheau, 44805 Nantes-St Herblain, France | Principal Investigator |
| Philippe LANG, oncologist | Hôpital de La Pitié Salpitrière, 75013 Paris, France | Principal Investigator |
| Isabelle TENNEVET, oncologist | Centre Henri Becquerel, 76038 Rouen, France | Principal Investigator |
| Patricia BURBAN, oncologist | Clinique Armoricaine de Radiologie, 22015 St Brieuc, France | Principal Investigator |
| Olivier GALLOCHER, oncologist | Clinique Pasteur, 31300 Toulouse, France | Principal Investigator |
| Olivier GALLOCHER, oncologist | Polyclinique du Parc, 31078 Toulouse, France | Principal Investigator |
| Yungan TAO, oncologist | Institut Gustave Roussy, 94805 Villejuif, France | Principal Investigator |
| Pierre BOISSELIER, oncologist | Val d'Aurelle 34298 Montpellier cedex | Principal Investigator |
| Frédéric PEYRADE, oncologist | Centre Antoine Lacassagne 06189 NICE cedex 2 | Principal Investigator |
| Marie SALIOU, oncologist | Clinique de l' Estuaire 44600 Pornichet | Principal Investigator |
| Cédrik LAFOND, oncologist | Centre Jean Bernard 72000 Le Mans | Principal Investigator |
| René-Jean BENSADOUN, oncologist | CHU 86021 Poitiers cedex | Principal Investigator |
| Alexandre COUTTE, oncologist | CHU Amiens sud 80004 Amiens | Principal Investigator |
| Hao QIU, oncologist | CHU 86000 Limoges | Principal Investigator |
| Florence HUGUET, oncologist | Hôpital Tenon 75020 Paris | Principal Investigator |
| Sébastien GUIHARD | Centre Paul Strauss 67065 Strasbourg | Principal Investigator |
| Xu Shan SUN, oncologist | Centre Hospitalier de Belfort Montbéliard Bd du Maréchal Juin 25200 Montbéliard | Principal Investigator |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |