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

Head and Neck Cancer Clinical Trial

Official title:

A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00093665
• Other study ID #: AICHI-UHA-HN03-01
• Secondary ID: CDR0000389425
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 6, 2004
• Last updated: May 14, 2013
• Start date: November 2003

Study information

• Verified date: October 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Aichi Cancer Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival at 3 years			No
Secondary	Overall survival			No
Secondary	Response rate			No
Secondary	Treatment completion rate			No
Secondary	Incidence of adverse effects			Yes