MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE.
- of either sex
- aged *15 and * 70 years
- never previously treated with radiotherapy, chemotherapy or surgery for malignant
disease (except neck adenectomy/diagnosis)
- with aWHO performance status * 2.
- amenable to regular follow-up
- capable of receiving chemotherapy and radiotherapy : in particular, with no
contraindications to the use of anthracyclines, bleomycin or cisplatinum.
- with informed consent at entry time, in writing or witnessed oral informed consent,
in accordance with local legislation requirements.
- Laboratory requirement : *Baseline hematologic status :
Neutrophil count * 2000 /mm3 Platelet count * 150,000 /mm3 Hemoglobin * 10 g / dl
- Histologic types other than type II - III of the WHO classification
- T1 - T2 N0 - N1 or patients with metastatic
- Aged < 15 or > 70.
- Patients in whom chemotherapy is contraindicated: history of myocardial infarction
over the last 6 months before inclusion, or clinically present cardiac pathology.
- WHO Performance status >2
- History of prior malignancies (other than non melanoma skin cancer or excised
cervical carcinoma in situ).
- Uncontrolled infection,
- Patients refusing participation.
- Patients who, for social, familial or geographic reasons are unlikely to comply with
a long term follow-up.