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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
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: surgical procedure Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 | |
| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00002951 History of Changes |
| Other Study ID Numbers: | CDR0000065421, UCCRC-8176, NU-V96N1, NCI-G97-1159 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
stage II esophageal cancer stage III esophageal cancer stage II nasopharyngeal cancer stage III nasopharyngeal cancer stage II lip and oral cavity cancer stage III lip and oral cavity cancer stage II hypopharyngeal cancer |
stage III hypopharyngeal cancer stage II laryngeal cancer stage III laryngeal cancer stage II paranasal sinus and nasal cavity cancer stage III paranasal sinus and nasal cavity cancer stage II oropharyngeal cancer stage III oropharyngeal cancer |
|
Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Fluorouracil Hydroxyurea Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antisickling Agents Hematologic Agents Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors |
