Head and Neck Cancer Clinical Trial
Official title:
A Multicenter Phase II Study of Intensified Concomitant Chemoradiotherapy for Patients With Anaplastic Thyroid Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
radiation therapy in treating patients who have previously untreated anaplastic thyroid
cancer.
OBJECTIVES: I. Evaluate the activity of chemotherapy with hyperfractionated radiotherapy in
terms of complete and overall response rate, time to progression, pattern of failure,
incidence of second primary tumors, and overall survival in patients with previously
untreated anaplastic thyroid cancer.
OUTLINE: This is a multicenter study. Patients receive oral hydroxyurea every 12 hours on
days 0-5, fluorouracil IV and paclitaxel IV continuously over days 1-5, and
hyperfractionated radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF)
subcutaneously daily on days 6-12. Treatment repeats every 2 weeks for 5 courses. Following
completion of concurrent chemoradiotherapy, patients with no prior initial modified neck
dissection who have residual macroscopic nodal disease or initially staged nodal disease
with no evidence of residual disease undergo neck dissection. Patients with macroscopic
residual disease at the primary site undergo complete excision of disease. Patients with any
progressive disease or recurrence of disease undergo conventional surgical management.
Patients are followed at 4-6 weeks, every 3 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 16-46 patients will be accrued for this study.
;
Primary Purpose: Treatment
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