Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
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|ClinicalTrials.gov Identifier: NCT00093665|
Recruitment Status : Unknown
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 8, 2004
Last Update Posted : May 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil|
|Study Start Date :||November 2003|
- Progression-free survival at 3 years
- Overall survival
- Response rate
- Treatment completion rate
- Incidence of adverse effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|