Controlled Randomized Trial to Evaluate Efficacy of Adjuvant Chemotherapy Between S-1 and UFT for Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Phase III Study
- Compare the disease-free survival rate in patients with definitively treated stage III
or IV squamous cell carcinoma of the head and neck treated with adjuvant chemotherapy
comprising S-1 vs tegafur-uracil (UFT).
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to primary site, disease stage, type of prior definitive treatment, and
participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral S-1 once daily on days 1-14. Courses repeat every 21 days
for 1 year in the absence of disease progression or unacceptable toxicity.
- Arm II:Patients receive oral tegafur-uracil (UFT) once daily on days 1-21. Courses
repeat every 21 days for 1 year in the absence of disease progression or unacceptable
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Mamoru Tsukuda, MD
Yokohama City University
United States: Federal Government