Esophageal Cancer Clinical Trial
Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
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 chemotherapy plus radiation therapy in treating patients with head and neck cancer.
Full Description
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 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
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There are 4 Locations for this study
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60640, United States
Evanston Illinois, 60201, United States
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