Docetaxel in Head and Neck Cancer

Study Overview
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Brief Summary
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Primary Objective: Phase II: To determine the best treatment scheme (TPF vs. PF). Phase III: To compare the time to progression and the treatment failure at the 3 arms. Secondary objectives: To evaluate the safety at the 3 arms. To compare the progression , overall survival and locoregional control at the 3 arms.

Official Title
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Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy
* Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy
* Other: Cisplatin + radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or larynx) but without evident metastasis. Inoperable tumor after revision by a multidisciplinary oncology team. Proved epidermoid carcinoma. ECOG = 0-1 Good hematologic function (i.e, hemoglobin > 10 g/dl, ...) Good hepatologic function Good renal function Exclusion Criteria: Pregnant or breast-feeding women. Potential child-bearing women should use an effective conceptive method and should have a negative pregnancy test at least the week before entering the study. Nasopharynx, nasal cavity and paranasal sinusitis will be excluded Previous chemotherapeutic or radiotherapeutic treatment for this disease. Previous or current neoplasms in other locations, except in situ cervicouterine cancer properly treated or basal cell or squamous cell carcinoma Symptomatic peripheral neuropathy Other clinical severe diseases Concomitant treatment with corticoids within 6 months prior to inclusion. Concomitant treatment with any other neoplastic therapy Previous treatment for current disease. Loss of weight greater than 10% within the last 3 months. 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

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: 1<br>(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy | Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy<br>* Docetaxel 75 mg/m2, Day 1 of the cycle + Cisplatin 75 mg/m2 Day 1 + 5-FU 750 mg/m2/day in 24-h continuous infusion for 5 days. 3 cycles will be administered, every 21 days, before the local-regional treatment (same as control group)<br>|
| Experimental: 2<br>(Cisplatin + 5-FU) + Cisplatin + Radiotherapy | Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy<br>* Cisplatin 100 mg/m2 Day 1, 5-FU 1000 mg/m2/day in 24-h continuous infusion for 5 consecutive days. 3 cycles will be administered every 21 days, before the local-regional treatment (same as control group)<br>|
| Experimental: 3<br>Cisplatin + Radiotherapy | Other: Cisplatin + radiotherapy<br>* Cisplatin 100 mg/m2 on days 1, 22 and 43 simultaneously with radiotherapy (2 Gy x 1/day, 5 days per week for 7 weeks-tumor- and 2 Gy x 1/day, 5 days per week for 6 weeks- lymph nodes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C). |  | 16 weeks | 
| Phase III: Surveillance with no progression after two years. |  | 2 years |