S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00336947
- Lead Sponsor
- Yokohama City University
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as S-1 and tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving S-1 or tegafur-uracil after surgery, chemotherapy, biological therapy, and/or radiation therapy may kill any remaining tumor cells. It is not yet known whether S-1 is more effective than tegafur-uracil in treating head and neck cancer.
PURPOSE: This randomized phase III trial is studying S-1 to see how well it works compared with tegafur-uracil in treating patients with previously treated stage III or stage IV head and neck cancer.
- Detailed Description
OBJECTIVES:
* Compare the disease-free survival rate in patients with definitively treated stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemotherapy comprising S-1 vs tegafur-uracil (UFT).
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to primary site, disease stage, type of prior definitive treatment, and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral S-1 once daily on days 1-14. Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.
* Arm II:Patients receive oral tegafur-uracil (UFT) once daily on days 1-21. Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method Relapse-free survival Overall survival Adverse effects
Trial Locations
- Locations (48)
Aichi Cancer Center
🇯🇵Nagoya, Aichi, Japan
Fujita Health University
🇯🇵Toyoake, Aichi, Japan
Akita University Hospital
🇯🇵Akita City, Akita, Japan
Tokyo Dental College Ichikawa General Hospital
🇯🇵Ichikawa, Chiba, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
National Kyushu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
Gifu University Graduate School of Medicine
🇯🇵Gifu-shi, Gifu, Japan
Gunma University Graduate School of Medicine
🇯🇵Maebashi, Gunma, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Cancer Center
🇯🇵Akashi City, Hyogo, Japan
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