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

Aichi Cancer Center

Status and phase: Unknown; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: fluorouracil; Drug: cisplatin; Radiation: radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00093665

CDR0000389425 (Registry Identifier)

AICHI-UHA-HN03-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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