Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 18 to 70 | Other | AICHI-UHA-HN03-01 NCT00093665 |
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.
Entry Criteria
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
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
Patient Characteristics:
Age
- 18 to 70
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC > 3,500/mm3
- Platelet count > 100,000/mm3
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
Expected Enrollment
90A total of 90 patients will be accrued for this study within 2 years.
Outcomes
Primary Outcome(s)Progression-free survival at 3 years
Overall survival
Response rate
Treatment completion rate
Incidence of adverse effects
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.
Trial Lead Organizations
Aichi Cancer Center
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| Nobukazu Fuwa, Protocol chair | |
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| Registry Information | ||
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| Official Title | A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil | |
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| Trial Start Date | 2003-11-01 | |
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| Registered in ClinicalTrials.gov | NCT00093665 | |
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| Date Submitted to PDQ | 2004-08-24 | |
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| Information Last Verified | 2006-10-01 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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