Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
Recruitment status was: Active, not recruiting
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.
|Head and Neck Cancer||Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil|
- Progression-free survival at 3 years
- Overall survival
- Response rate
- Treatment completion rate
- Incidence of adverse effects
|Study Start Date:||November 2003|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093665
|National Hospital Organization - Medical Center of Kure|
|Hiroshima, Japan, 737-0023|
|Kanazawa, Japan, 920-8641|
|Kyoto Prefectural University of Medicine|
|Kyoto, Japan, 602|
|Aichi Cancer Center|
|Nagoya, Japan, 464-8681|
|Nara Medical University Cancer Center|
|Nara, Japan, 634-8522|
|Graduate School of Medical Science at the University of Ryukyu|
|Okinawa, Japan, 903-0215|
|Mie University School of Medicine|
|Tsu, Japan, 514-8507|
|Study Chair:||Nobukazu Fuwa||Aichi Cancer Center|