To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Sanofi-Aventis
Milan, Italy
Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment
Time frame: from end of treatment until 6-8 weeks
Duration of response
Time frame: from the date of first documented tumor response to the date of first documented tumor progression
Time to disease progression
Time frame: From the date of the treatment start to the date of first documented progression of disease
Time to treatment failure
Time frame: from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause
Median length of overall survival
Time frame: time interval from the date of treatment to the date of death
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