A Randomized Phase III Trial Comparing Sequential Therapy With TPF/ Chemoradiation (ST) to Cisplatinum-Based Chemoradiotherapy With Accelerated Concomitant Boost Radiotherapy (CRT) For Locally Advanced Squamous Cell Cancer of the Head and Neck ("The Paradigm Study")
Inclusion Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
Stage III or IV* disease
One of the following primary tumor sites:
Oral cavity
No mandible invasion Oropharynx Hypopharynx Larynx
The following primary tumor sites are excluded:
Nasal cavity Paranasal cavity Nasopharynx NOTE: *No evidence of distant metastases by
chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function test
abnormalities) or bone scan (for patients with local symptoms) At least 1 uni- or
bi-dimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age
Over 18 Performance status
WHO 0-1 Life expectancy
Not specified Hematopoietic
Neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 10 g/dL Hepatic
Bilirubin normal AST or ALT within eligibility range Alkaline phosphatase within
eligibility range Renal
Creatinine clearance > 60 mL/min Cardiovascular
No unstable cardiac disease despite treatment No myocardial infarction within the past 6
months Pulmonary
No chronic obstructive pulmonary disease, defined as requiring hospitalization for
pneumonia or respiratory decompensation within the past year
Obstruction caused by the tumor allowed Neurologic
No symptomatic peripheral neuropathy > grade 2 No symptomatic altered hearing > grade 2 No
history of significant neurologic or psychiatric disorders, including dementia or seizures
Other
No active drug addiction, including alcohol, cocaine, or intravenous drugs within the past
6 months No other malignancy within the past 5 years except adequately treated carcinoma
in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively
treated by surgery alone No active, clinically significant, uncontrolled infection No
autoimmune disease requiring therapy No unhealed or clinically active peptic ulcer disease
No hypercalcemia No other serious illness or medical condition No involuntary weight loss
> 25% of body weight within the past 2 months HIV negative Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for
at least 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified Chemotherapy
No prior chemotherapy Endocrine therapy
Not specified Radiotherapy
No prior radiotherapy Surgery
No prior organ transplantation No prior surgery for this cancer
Biopsy allowed Other
More than 30 days since prior participation in another investigational study No other
concurrent anticancer therapy