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Status:

UNKNOWN

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

Lead Sponsor:

Aichi Cancer Center

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

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-ra...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    90 Patients enrolled

    Trial Details

    Trial ID

    NCT00093665

    Start Date

    November 1 2003

    Last Update

    May 15 2013

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    National Hospital Organization - Medical Center of Kure

    Hiroshima, Japan, 737-0023

    2

    Kanazawa University

    Kanazawa, Japan, 920-8641

    3

    Kyoto Prefectural University of Medicine

    Kyoto, Japan, 602

    4

    Aichi Cancer Center

    Nagoya, Japan, 464-8681