This trial is active, not recruiting.

Condition head and neck cancer
Treatments cisplatin, fluorouracil, radiation therapy
Phase phase 2
Sponsor Aichi Cancer Center
Start date November 2003
Trial size 90 participants
Trial identifier NCT00093665, AICHI-UHA-HN03-01, CDR0000389425


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Progression-free survival at 3 years
time frame:

Secondary Outcomes

Overall survival
time frame:
Response rate
time frame:
Treatment completion rate
time frame:
Incidence of adverse effects
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).