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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.
The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy followed by postoperative radiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPF | Experimental | Docetaxel, Cisplatine, 5-FU |
|
| PF | Active Comparator | Cisplatine, 5-FU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOCETAXEL | Drug | 75 mg/m 2 on day 1 |
| |
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| 3-years larynx preservation rate |
| Measure | Description | Time Frame |
|---|---|---|
| 5-years survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Calais, MD | CHU Bretonneau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bretonneau | Tours | 37044 | France |
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| Drug |
75 mg/m 2 on day 1 |
|
| 5-Fluoro-3-Pyridinecarboxylic Acid | Drug | 750 mg/m 2 by 24-hour continuous infusion for 5 days |
|
| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| C023498 | 5-fluoro-3-pyridinecarboxylic acid |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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