Docetaxel in Head and Neck Cancer

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).

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.

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.