A Multicenter Phase II Study of Intensified Concomitant Chemoradiotherapy for Patients With Anaplastic Thyroid Cancer

Trial Information

A Multicenter Phase II Study of Intensified Concomitant Chemoradiotherapy for Patients With 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.