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

NCT ID: NCT00093665

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30

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.

Conditions

Head and Neck Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aichi Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Nobukazu Fuwa

Role: STUDY_CHAIR

Aichi Cancer Center

Locations

National Hospital Organization - Medical Center of Kure

Hiroshima, , Japan

Kanazawa University

Kanazawa, , Japan

Kyoto Prefectural University of Medicine

Kyoto, , Japan

Aichi Cancer Center

Nagoya, , Japan

Nara Medical University Cancer Center

Nara, , Japan

Graduate School of Medical Science at the University of Ryukyu

Okinawa, , Japan

Mie University School of Medicine

Tsu, , Japan

Countries

Japan

Other Identifiers

CDR0000389425

Identifier Type: REGISTRY

Identifier Source: secondary_id

AICHI-UHA-HN03-01

Identifier Type: -

Identifier Source: org_study_id