Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in 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 fluorouracil and cisplatin with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II, stage III, or stage IV nasopharyngeal cancer.

Detailed Description
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OBJECTIVES: Primary Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy. Secondary Determine overall survival and response rate in patients treated with this regimen. Determine compliance to this regimen in these patients. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.

Official Title
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A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: fluorouracil
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed nasopharyngeal cancer (NPC) Type I-III disease by WHO classification Stage IIB-IVB disease by TNM classification with no distant metastases by chest x-ray, liver ultrasonography or CT scan, and bone scintigraphy Lymph node metastases evaluated by CT scan, MRI, and palpation Progression range of primary lesion evaluated by MRI and pharyngeal fiberoptic endoscopy PATIENT CHARACTERISTICS: Age 18 to 70 Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC > 3,500/mm^3 Platelet count > 100,000/mm^3 Hepatic No severe hepatic dysfunction Renal Creatinine clearance > 60 mL/min No severe renal dysfunction Cardiovascular No severe cardiac dysfunction Pulmonary No severe pulmonary dysfunction Other No other active cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for NPC Chemotherapy No prior systemic chemotherapy for NPC Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

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
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival at 3 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Response rate |  |  | 
| Treatment completion rate |  |  | 
| Incidence of adverse effects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx