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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.
Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC) administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires antiemetic treatment and blood pressure monitoring in both arms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethyol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Late xerostomia rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etienne Bardet, MD | Centre Régional de Lutte contre le Cancer de Nantes-Atlantique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Régional de Lutte contre le Cancer de Nantes-Atlantique | Nantes | 44805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12577246 | Background | Bardet E, Martin L, Calais G, Tuchais C, Bourhis J, Rhein B, Feham N, Alphonsi M. Preliminary data of the GORTEC 2000-02 phase III trial comparing intravenous and subcutaneous administration of amifostine for head and neck tumors treated by external radiotherapy. Semin Oncol. 2002 Dec;29(6 Suppl 19):57-60. doi: 10.1053/sonc.2002.37348. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D004999 | Amifostine |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| D009057 |
| Stomatognathic Diseases |
| D009946 |
| Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |