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


Phase 2
15 Years
80 Years
Not Enrolling
Both
Head and Neck Cancer

Thank you

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed anaplastic thyroid
cancer Metastatic disease allowed

PATIENT CHARACTERISTICS: Age: 15 to 80 Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Alkaline phosphatase no greater than 2 times
normal Transaminases no greater than 2 times normal Renal: Not specified

PRIOR CONCURRENT THERAPY: Prior simple excision (e.g., transoral laser excision) of the
primary lesion allowed if organ function preserved Prior modified neck dissection allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Merrill S. Kies, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

NU V96N3

NCT ID:

NCT00004089

Start Date:

August 1999

Completion Date:

April 2002

Related Keywords:

  • Head and Neck Cancer
  • anaplastic thyroid cancer
  • Thyroid Neoplasms
  • Head and Neck Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
University of Illinois at ChicagoChicago, Illinois  60612