Trial Information

Induction Chemotherapy Followed By Chemoradiation For Organ Preservation In Patients With Advanced Resectable Cancer Of The Hypopharynx And Base Of Tongue, Phase II

OBJECTIVES: I. Determine the complete histologic response rate (which represents the rate of
organ preservation) to induction with cisplatin/fluorouracil followed by radiotherapy plus
cisplatin in patients with selected stage III/IV cancer of the hypopharynx or base of the
tongue. II. Evaluate the feasibility of accruing and treating patients with this regimen in
a multi-institutional setting. III. Determine the overall complete response rate in these
patients.

OUTLINE: This is a multicenter study. Patients are stratified according to center and tumor
site (hypopharynx vs base of tongue). Base of tongue stratum closed as of November 15, 1998.
Regimen A: Patients receive cisplatin IV over 90 minutes on days 1 and 22 and fluorouracil
IV over 120 minutes on days 1-5 and 22-26. Patients with measurable neck nodes discontinue
therapy if disease has progressed by day 22. All patients who achieve complete or partial
response at day 43 proceed to regimen B. All others proceed to resection followed by
radiotherapy (off study). Regimen B (begins within 3-4 weeks of start of second induction
course): Patients receive cisplatin IV over 90 minutes every 3 weeks for 3 courses.
Concurrently, patients receive radiotherapy 5 days a week for 5.6 weeks. Patients are
reassessed at 8-12 weeks after radiotherapy. Patients who are disease free are observed.
Other patients undergo surgical resection of nodes and/or primary tumor. Patients are
followed every 4-6 weeks for 1 year, every 2 months for 1 year, every 4 months for 2 years,
every 6 months for 1 year, then annually thereafter.

PROJECTED ACCRUAL: Up to 70 patients (35/tumor site) will be accrued for this study over 3.5
years.