Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 70	Other	AICHI-UHA-HN03-01 NCT00093665

Objectives

Primary

1. Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy.

Secondary

1. Determine overall survival and response rate in patients treated with this regimen.
2. Determine compliance to this regimen in these patients.
3. Determine the toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 to 70

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC > 3,500/mm³
• Platelet count > 100,000/mm³

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

Expected Enrollment

A total of 90 patients will be accrued for this study within 2 years.

Outcomes

Progression-free survival at 3 years

Overall survival
Response rate
Treatment completion rate
Incidence of adverse effects

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.

Trial Contact Information

Trial Lead Organizations

Aichi Cancer Center

Nobukazu Fuwa, Protocol chair		Ph: 81-52-762-6111

Registry Information
Official Title		A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
Trial Start Date		2003-11-01
Registered in ClinicalTrials.gov		NCT00093665
Date Submitted to PDQ		2004-08-24
Information Last Verified		2006-10-01

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