Standard Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Adjuvant Chemotherapy for Locally Advanced (Non-Metastatic) Nasopharyngeal Cancer

OBJECTIVES: Compare the clinical response, distant metastases, disease-free survival, and overall survival in patients with previously untreated, locally advanced, nonmetastatic nasopharyngeal cancer treated with radiotherapy alone vs concurrent chemoradiotherapy followed by adjuvant chemotherapy. OUTLINE: This is a randomized study. Patients are randomized to receive radiotherapy alone (arm I) or concurrent chemoradiotherapy followed by adjuvant chemotherapy (arm II). Arm I: Patients receive radiotherapy once daily 5 times a week for 7 weeks. Arm II: Patients receive cisplatin IV over 6-8 hours for 4 consecutive days every 3 weeks for 3 courses. Concurrent radiotherapy is given once daily 5 times a week over the 7 week treatment period. This chemoradiotherapy is followed 3 weeks later by adjuvant chemotherapy. Patients receive cisplatin IV and fluorouracil IV over 6-8 hours for 4 consecutive days every 4 weeks for 3 courses. Patients are followed every 4 months for the first year, every 6 months for the next 2 years, and then annually thereafter until death. PROJECTED ACCRUAL: A minimum of 200 patients will be accrued for this study.