Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004089
Recruitment Status : Completed
First Posted : September 14, 2004
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Biological: filgrastim Drug: fluorouracil Drug: hydroxyurea Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of Intensified Concomitant Chemoradiotherapy for Patients With Anaplastic Thyroid Cancer
Study Start Date : August 1999
Actual Primary Completion Date : April 2002
Actual Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004089

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Merrill S. Kies, MD M.D. Anderson Cancer Center Identifier: NCT00004089     History of Changes
Other Study ID Numbers: NU V96N3
First Posted: September 14, 2004    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: January 2011

Keywords provided by National Cancer Institute (NCI):
anaplastic thyroid cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Thyroid Neoplasms
Thyroid Carcinoma, Anaplastic
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antisickling Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors