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

This study is ongoing, but not recruiting participants.
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: October 6, 2004
Last updated: May 14, 2013
Last verified: October 2006

October 6, 2004
May 14, 2013
November 2003
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Progression-free survival at 3 years
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Complete list of historical versions of study NCT00093665 on ClinicalTrials.gov Archive Site
  • Overall survival
  • Response rate
  • Treatment completion rate
  • Incidence of adverse effects
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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.



  • 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.

Phase 2
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
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  • 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
AICHI-UHA-HN03-01, CDR0000389425
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Aichi Cancer Center
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Study Chair: Nobukazu Fuwa Aichi Cancer Center
National Cancer Institute (NCI)
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP