Trial Information

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.