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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer  Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
For Condition: Gastrointestinal Cancer,Throat Cancer,Oral Cancer,Neck Cancer
Status: No longer recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed diagnosis of carcinoma - Stage II-III (T2, T3, N0 or T1-3, N1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus - No N2 or N3 - Measurable disease is not required PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-3 Life expectancy: - Anticipated survival is 3-4 years (median) Hematopoietic: - WBC count at least 3.5/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Not specified Renal: - Not specified Cardiovascular: - Not specified Pulmonary: - Not specified Other: - No infection or severe medical illness - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - No prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EverettVokes, Study Chair, University of Chicago Cancer Research Center
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: CDR0000065421; UCCRC-8176,NU-V96N1,NCI-G97-1159
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002951
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Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
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