Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility
OBJECTIVES: I. Determine the toxicity of fluorouracil and cisplatin with concurrent
radiotherapy in patients with stage I-IVB squamous cell cancer of the head and neck at high
risk of recurrence following curative resection. II. Determine the efficacy of this regimen
in these patients. III. Determine the survival of these patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive fluorouracil IV continuously on days
1-5 and 43-47 and cisplatin IV over 1 hour on days 2, 23, and 44. Concurrent radiotherapy is
administered 5 days a week for 6.5 weeks. Patients are followed every 3 months for 2 years,
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 44-68 patients will be accrued for this study within 18
months.
Interventional
Primary Purpose: Treatment
Lionnel Geoffrois, MD
Study Chair
Centre Alexis Vautrin
United States: Federal Government
CDR0000068073
NCT00006051
February 1999
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