Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck

Conditions
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Esophageal Cancer, Head and Neck Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Drug: hydroxyurea
* Procedure: surgical procedure
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (Hyper-FHX)<br>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<br> <br> Drug: hydroxyurea<br> <br> Procedure: surgical procedure<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control rate |  | 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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