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

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

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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: fluorouracil; Radiation: radiation therapy; Drug: cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan, 737-0023
    • National Hospital Organization - Medical Center of Kure
  • Kanazawa, Japan, 920-8641
    • Kanazawa University
  • Kyoto, Japan, 602
    • Kyoto Prefectural University of Medicine
  • Nagoya, Japan, 464-8681
    • Aichi Cancer Center
  • Nara, Japan, 634-8522
    • Nara Medical University Cancer Center
  • Okinawa, Japan, 903-0215
    • Graduate School of Medical Science at the University of Ryukyu
  • Tsu, Japan, 514-8507
    • Mie University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival at 3 years

Secondary Outcome Measures

Outcome Measure
Response rate
Overall survival
Treatment completion rate
Incidence of adverse effects

Collaborators and Investigators

• Sponsor: Aichi Cancer Center
• Investigators: Study Chair: Nobukazu Fuwa, Aichi Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2003

Study Registration Dates

• First Submitted: October 6, 2004
• First Submitted That Met QC Criteria: October 7, 2004
• First Posted (Estimate): October 8, 2004

Study Record Updates

• Last Update Posted (Estimate): May 15, 2013
• Last Update Submitted That Met QC Criteria: May 14, 2013
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Keywords: stage III squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage II lymphoepithelioma of the nasopharynx
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil
• Other Study ID Numbers: AICHI-UHA-HN03-01; CDR0000389425 (Registry Identifier: PDQ (Physician Data Query))