Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Treatments||cisplatin, fluorouracil, radiation therapy|
|Sponsor||Aichi Cancer Center|
|Start date||November 2003|
|Trial size||90 participants|
|Trial identifier||NCT00093665, AICHI-UHA-HN03-01, CDR0000389425|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Hiroshima, Japan||National Hospital Organization - Medical Center of Kure||no longer recruiting|
|Kanazawa, Japan||Kanazawa University||no longer recruiting|
|Kyoto, Japan||Kyoto Prefectural University of Medicine||no longer recruiting|
|Nagoya, Japan||Aichi Cancer Center||no longer recruiting|
|Nara, Japan||Nara Medical University Cancer Center||no longer recruiting|
|Okinawa, Japan||Graduate School of Medical Science at the University of Ryukyu||no longer recruiting|
|Tsu, Japan||Mie University School of Medicine||no longer recruiting|
Progression-free survival at 3 years
Treatment completion rate
Incidence of adverse effects
Male or female participants from 18 years up to 70 years old.
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
|Official title||A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil|
|Description||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.|
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