Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

Conditions
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Larynx Cancer, Hypopharynx Cancer

Intervention / Treatment
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* Drug: DOCETAXEL
* Drug: Cisplatin
* Drug: 5-Fluoro-3-Pyridinecarboxylic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy Biopsy proven carcinoma Adequate biology Performance status 0 or 1 Exclusion Criteria: Larynx or hypopharynx tumors that could be treated with partial laryngectomy Distant metastasis Prior surgery, chemotherapy or radiation Intercurrent disease that is a contra indication to chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPF<br>Docetaxel, Cisplatine, 5-FU | Drug: DOCETAXEL<br>* 75 mg/m 2 on day 1<br>Drug: Cisplatin<br>* 75 mg/m 2 on day 1<br>Drug: 5-Fluoro-3-Pyridinecarboxylic Acid<br>* 750 mg/m 2 by 24-hour continuous infusion for 5 days<br>|
| Active Comparator: PF<br>Cisplatine, 5-FU | Drug: Cisplatin<br>* 75 mg/m 2 on day 1<br>Drug: 5-Fluoro-3-Pyridinecarboxylic Acid<br>* 750 mg/m 2 by 24-hour continuous infusion for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-years larynx preservation rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-years survival rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Larynx cancer, Hypopharynx cancer, Chemotherapy, Randomized trial, Larynx preservation