Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications
About this trial
This is an interventional treatment trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer, oral complications, drug/agent toxicity by tissue/organ, radiation toxicity
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed undifferentiated nasopharyngeal cancer (UNPC) Locoregionally advanced disease T2b, N1 (greater than 3 cm) or N2 T3, N1 (greater than 3 cm) or N2 T4, N1 (greater than 3 cm) or N2 Any T, N3 No squamous cell histology At least 1 unidimensionally measurable target lesion At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan No evidence of distant metastases No signs or symptoms of CNS metastases PATIENT CHARACTERISTICS: Age: 15 to 70 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 12 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal: Creatinine clearance at least 70 mL/min Calcium normal Cardiovascular: No hypotension or hypertension requiring therapy No prior myocardial infraction No pre-existing uncontrolled cardiac disease No signs of cardiac failure No rhythm disturbances requiring medication Other: No sensory neuropathy grade 2 or greater unless due to cranial nerve No uncontrolled infections No sensitivity to aminothiol compounds No other malignancy within the past 5 years except adequately controlled carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No psychological, familial, sociological, or geographical condition that would preclude study Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy for UNPC Endocrine therapy: No concurrent hormonal therapy except corticosteroids for antiemetic prophylaxis Radiotherapy: No prior radiotherapy for UNPC Surgery: No prior surgery for UNPC except cervical lymphadenectomy Other: At least 1 month since prior investigational agent No other concurrent anticancer drugs
Sites / Locations
- Institut Jules Bordet
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- CRLCC Nantes - Atlantique
- Centre Antoine Lacassagne
- Ospedale Santa Croce
- Istituto Nazionale per la Ricerca sul Cancro
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Hospital General de Jerez
- Hospital Universitario 12 de Octubre
- Istanbul University-Institute of Oncology
- Beatson Oncology Centre