Trial Information

RANDOMIZED TRIAL OF NEOADJUVANT CHEMOTHERAPY AND SURGERY +/- RADIOTHERAPY VERSUS SURGEERY +/- RADIOTHERAPY IN OPERABLE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY

OBJECTIVES: I. Assess the short- and long-term local control rates, disease-free survival,
and overall survival following treatment with neoadjuvant cisplatin plus fluorouracil
followed by surgery with or without radiotherapy vs surgery alone with or without
radiotherapy in patients with previously untreated stage II-IV squamous cell carcinoma of
the oral cavity. II. Assess the prognostic significance of clinical and pathologic responses
to neoadjuvant chemotherapy in these patients. III. Compare the short- and long-term toxic
effects of these two regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and
nodal status (N0 vs N1-2 vs N3). Patients are randomized to one of two treatment arms. Arm
I: Patients receive cisplatin IV on day 1 and fluorouracil IV continuously on days 1-5.
Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable disease after 2 courses or progressive disease
at any time proceed to surgery. Patients undergo resection of the primary tumor site and
possible nodal dissection no sooner than 2 weeks after completion of chemotherapy. Patients
then undergo radiotherapy over 5-6 weeks no later than 8 weeks after surgery. Arm II:
Patients undergo surgery and radiotherapy as in arm I. Patients are followed every 3 months
for 1 year, every 6 months for 2 years, and then yearly thereafter.

PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 9 years.