Head and Neck Cancer
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DRUGcisplatin
DRUGfluorouracil
RADIATIONradiation therapy
Sponsors
Aichi Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
| Response rate | — |
| Treatment completion rate | — |
| Incidence of adverse effects | — |
Countries
Japan
Outcome results
None listed