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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093665
Recruitment Status : Unknown
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2004
Last Update Posted : May 15, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy Phase 2

Detailed Description:



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


  • 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  (Clinical Trial)
Estimated Enrollment : 90 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
Study Start Date : November 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival at 3 years

Secondary Outcome Measures :
  1. Overall survival
  2. Response rate
  3. Treatment completion rate
  4. Incidence of adverse effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 70

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC > 3,500/mm^3
  • Platelet count > 100,000/mm^3


  • No severe hepatic dysfunction


  • Creatinine clearance > 60 mL/min
  • No severe renal dysfunction


  • No severe cardiac dysfunction


  • No severe pulmonary dysfunction


  • No other active cancer


Biologic therapy

  • No prior biologic therapy for NPC


  • No prior systemic chemotherapy for NPC

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093665

National Hospital Organization - Medical Center of Kure
Hiroshima, Japan, 737-0023
Kanazawa University
Kanazawa, Japan, 920-8641
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602
Aichi Cancer Center
Nagoya, Japan, 464-8681
Nara Medical University Cancer Center
Nara, Japan, 634-8522
Graduate School of Medical Science at the University of Ryukyu
Okinawa, Japan, 903-0215
Mie University School of Medicine
Tsu, Japan, 514-8507
Sponsors and Collaborators
Aichi Cancer Center
Study Chair: Nobukazu Fuwa Aichi Cancer Center Identifier: NCT00093665     History of Changes
Other Study ID Numbers: AICHI-UHA-HN03-01
CDR0000389425 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: October 2006

Keywords provided by National Cancer Institute (NCI):
stage II lymphoepithelioma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs