A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
18 Years
70 Years
Both
Head and Neck Cancer
Trial Information
A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival at 3 years
Safety Issue:
No
Principal Investigator
Nobukazu Fuwa
Investigator Role:
Study Chair
Investigator Affiliation:
Aichi Cancer Center
Authority:
United States: Federal Government
Study ID:
AICHI-UHA-HN03-01
NCT ID:
NCT00093665
Start Date:
November 2003
Completion Date:
Related Keywords:
- Head and Neck Cancer
- 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
- Head and Neck Neoplasms
- Nasopharyngeal Neoplasms
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