A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere) Plus Cisplatin Plus 5-Fluorouracil Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
OBJECTIVES: I. Compare the progression free survival of patients with locally advanced,
inoperable squamous cell carcinoma of the head and neck treated with cisplatin plus
fluorouracil with or without docetaxel as a neoadjuvant to radiotherapy. II. Compare the
response rate, response duration, toxicity, local symptoms, and time to disease progression
of these treatment regimens in this patient population. III. Evaluate the quality of life in
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
primary tumor site (oral cavity vs oropharynx vs hypopharynx vs larynx) and institution.
Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV
over 1 hour, immediately followed by cisplatin IV over 1 hour on day 1 and fluorouracil
(5-FU) IV as a continuous infusion on days 1-5. Arm II: Patients receive cisplatin IV over 1
hour on day 1 followed by 5-FU IV as a continuous infusion on days 1-5. Treatment continues
every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients receive radiotherapy following chemotherapy within 3-6 weeks of last course.
Radiotherapy is administered 5 days a week for up to 7 weeks. Quality of life is assessed
before treatment, at courses 2 and 4, and at 6 and 9 months. Patients are followed every 3
months for the first 2 years and then every 6 months until death.
PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study within 24 months.
Allocation: Randomized, Primary Purpose: Treatment
Jan B. Vermorken, MD, PhD
Universitair Ziekenhuis Antwerpen
United States: Federal Government