Trial Information

A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, With and Without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients With Advanced Oropharyngeal Squamous Cell Cancer

OBJECTIVES:

Primary

- Compare the overall survival of patients with previously untreated stage III or IV
squamous cell carcinoma of the oropharynx treated with induction chemotherapy
comprising docetaxel, cisplatin, and fluorouracil followed by radiotherapy and
cisplatin versus radiotherapy and cisplatin only.

- Compare the progression-free survival in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life and functional status of patients treated with these
regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
primary cancer site (base of tongue vs other), nodal extent (N0-1 vs N2-3), radiotherapy
plan (conventional [2-D or 3-D conformal radiotherapy] vs intensity modulated radiotherapy).
Patients are randomized to 1 of 2 treatment arms.

- Arm I (induction chemotherapy with or without salvage surgery followed by
chemoradiotherapy)

- Induction chemotherapy with or without early salvage surgery: Patients receive
docetaxel IV over 1 hour and cisplatin over 30-60 minutes on day 1 and
fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 1-3
courses. Patients achieving complete or partial response at the primary site after
course 1 receive 2 additional courses of therapy and then proceed to
chemoradiotherapy within 3-4 weeks after completion of fluorouracil
administration. Patients with stable disease or surgically resectable locoregional
disease progression undergo early salvage surgery and then proceed to concurrent
chemoradiotherapy within 70 days after surgery. Patients with locoregional
unresectable disease progression or patients who refused early salvage surgery
proceed directly to concurrent chemoradiotherapy within 3-4 weeks after completion
of fluorouracil administration.

- Chemoradiotherapy: Patients undergo 2-D or 3-D conformal radiotherapy or intensity
modulated radiotherapy once daily 5 days a week for 7 weeks and receive cisplatin
IV over 30-60 minutes concurrently on days 1, 22, and 43* in the absence of
disease progression or unacceptable toxicity.

NOTE: *Patients undergoing surgery before chemoradiotherapy receive cisplatin on days 1 and
22 only of a 6-week course of radiotherapy.

- Arm II (chemoradiotherapy only): Patients undergo 2-D or 3-D conformal radiotherapy or
intensity modulated radiotherapy once daily 5 days a week for 7 weeks and receive
cisplatin IV over 30-60 minutes on days 1, 22, and 43 in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline, after completion of chemoradiotherapy, and then at
12 months after randomization.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: Approximately 398 patients (199 per treatment arm) will be accrued for
this study.