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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093665
First received: October 6, 2004
Last updated: May 14, 2013
Last verified: October 2006

October 6, 2004
May 14, 2013
November 2003
Not Provided
Progression-free survival at 3 years [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00093665 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Treatment completion rate [ Designated as safety issue: No ]
  • Incidence of adverse effects [ Designated as safety issue: Yes ]
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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.

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.

Interventional
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
90
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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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00093665
AICHI-UHA-HN03-01, CDR0000389425
Not Provided
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Aichi Cancer Center
Not Provided
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