Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).

Official Title
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A Multicenter, Randomized, Phase II Study of the Combination of Docetaxel (TAXOTERE) and Concomitant Radiotherapy With or Without Cisplatin in Patients With Locally Advanced Head and Neck Cancer

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Drug: docetaxel and cisplatin
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx. Locally advanced tumors which are inoperable, or operable but the patient refuses surgery. Age ≥ 18 years and ≤ 70 years. PS < 2. Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT > 1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial. Exclusion Criteria: Any metastases (other than cervical ganglia). Cancer of the cavum and the facial structure. Any previous chemotherapy or radiotherapy, irrespective of the reason. Any surgery for epidermoid carcinoma in the upper aerodigestive tracts. Weight loss ≥10% of total body weight during the last 3 months. Any other previous cancer excepting in situ or cutaneous cervical cancer (spinocellular or basocellular). Pregnant or nursing women; women of childbearing potential must use an appropriate method of contraception. Poorly controlled progressive infection. Peripheral neuropathy with NCI grade ≥ 2. Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment. Any other poorly controlled progressive disease, such as heart failure, symptomatic cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment. Any other concomitant investigational treatment. Any other concomitant anticancer treatment. Allergy to polysorbate 80. Definitive formal contraindication to corticosteroids. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: docetaxel and cisplatin<br> | Drug: docetaxel and cisplatin<br> <br> |
| Experimental: docetaxel<br> | Drug: docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rates |  | evaluated 8 weeks after the end of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the responses and overall survival |  | time until progression |