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).
- 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
- 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.