Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether surgery plus radiation therapy is more effective than chemotherapy plus radiation therapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying surgery and radiation therapy to see how well they work compared to chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer that can be removed during surgery.

Detailed Description
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OBJECTIVES: Compare the complete response rate, disease-free survival, and overall survival of patients with resectable (nonmetastatic) stage III or IV squamous cell cancer of the head and neck treated with surgery and adjuvant radiotherapy versus concurrent chemo-radiotherapy. OUTLINE: This is a randomized study. Patients are stratified according to primary site of disease (oral cavity/oropharynx vs larynx/hypopharynx vs others) and nodal status (node negative vs positive). Arm I: Patients undergo resection of the tumor, followed no more than 6 weeks later by radiotherapy to the primary tumor and upper neck once a day, 5 days a week, for 6 weeks. Arm II: Patients undergo radiotherapy in addition to chemotherapy with fluorouracil and cisplatin. Radiotherapy is given once a day, 5 days a week, for 6.5 weeks to the primary tumor and upper neck. Fluorouracil and cisplatin are administered by continuous infusion for 4 days beginning on day 1 of the first week of radiotherapy. A second course of fluorouracil and cisplatin is given on day 28. Patients who have failed or are suspected to have failed chemo-radiotherapy should be considered for salvage surgery. Patients are followed once a month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months thereafter. PROJECTED ACCRUAL: Approximately 200 patients will be accrued over a 4-5 year period.

Official Title
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Surgery and Adjuvant Radiotherapy Versus Concurrent Chemo-Radiotherapy for Resectable (Non-Metastatic) Stage III/IV Head and Neck Squamous Cell Cancer

Conditions
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Head and Neck Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed head and neck squamous cell cancer (excluding nasopharynx and salivary glands) on biopsy of the primary lesion or the neck mass Stage III or IV disease No evidence of distant or systemic metastases Resectable disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: SGOT less than 2 times upper limit of normal Bilirubin less than 1.4 mg/dL Renal: Creatinine less than 1.6 mg/dL Other: No prior or concurrent primary malignancies Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: See Disease Characteristics No prior surgery (other than biopsy)
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
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: fluorouracil|nan|
|Procedure: surgical procedure|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response at 6 weeks after completion of study treatment |  |  | 
| Disease-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity