• Progression-free survival at 3 years [ Designated as safety issue: No ]
  

• Overall survival [ Designated as safety issue: No ]
  
• Response rate [ Designated as safety issue: No ]
  
• Treatment completion rate [ Designated as safety issue: No ]
  
• Incidence of adverse effects [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy.

Secondary

• Determine overall survival and response rate in patients treated with this regimen.
• Determine compliance to this regimen in these patients.
• Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed nasopharyngeal cancer (NPC)

  • Type I-III disease by WHO classification

  • Stage IIB-IVB disease by TNM classification with no distant metastases by chest x-ray, liver ultrasonography or CT scan, and bone scintigraphy

    • Lymph node metastases evaluated by CT scan, MRI, and palpation
  • Progression range of primary lesion evaluated by MRI and pharyngeal fiberoptic endoscopy

PATIENT CHARACTERISTICS:

Age

• 18 to 70

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC > 3,500/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• No severe hepatic dysfunction

Renal

• Creatinine clearance > 60 mL/min
• No severe renal dysfunction

Cardiovascular

• No severe cardiac dysfunction

Pulmonary

• No severe pulmonary dysfunction

Other

• No other active cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for NPC

Chemotherapy

• No prior systemic chemotherapy for NPC

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified