Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck 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 chemotherapy plus radiation therapy in treating patients with head and neck cancer.
Head and Neck Cancer
Procedure: surgical procedure
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck|
- Locoregional control rate [ Time Frame: 8 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 1996|
|Study Completion Date:||July 2006|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
Experimental: Arm A (Hyper-FHX)
Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)
|Drug: fluorouracil Drug: hydroxyurea Procedure: surgical procedure Radiation: radiation therapy|
- Determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus.
- Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ function and quality of life parameters.
- Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring.
OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure.
The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles.
The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002951
|United States, Illinois|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|CCOP - Evanston|
|Evanston, Illinois, United States, 60201|
|Study Chair:||Everett E. Vokes, MD||University of Chicago|