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| Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002951 |
Purpose
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.
| Condition | Intervention | Phase |
|
Esophageal Cancer Head and Neck Cancer |
Drug: fluorouracil Drug: hydroxyurea Procedure: radiation therapy Procedure: surgical procedure |
Phase II |
| MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer |
| ChemIDplus related topics: | Hydroxyurea Fluorouracil Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 1996 |
OBJECTIVES:
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |||||
| CCOP - Evanston | |||||
| Evanston, Illinois, United States, 60201 | |||||
| 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 | |||||
| University of Chicago |
| National Cancer Institute (NCI) |
| Study Chair: | Everett E. Vokes, MD | University of Chicago |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000065421, UCCRC-8176, NU-V96N1, NCI-G97-1159 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002951 |
| Health Authority: | United States: Federal Government |
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