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
Radiation: radiation therapy
|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 [ Designated as safety issue: No ]
- 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 ]
|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|