Controlled Randomized Trial to Evaluate Efficacy of Adjuvant Chemotherapy Between S-1 and UFT for Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Phase III Study
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 96
- 主要终点
- Disease-free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
- •Stage III or IV disease
- •Primary tumor in the mesopharynx, hypopharynx, larynx (except T3 N0 tumors of the glottis), oral cavity, or maxillary sinus
- •Completed definitive treatment for SCCHN within the past 3 months, that included any of the following:
- •Chemotherapy
- •Biologic therapy
- •Radiotherapy (e.g., radiotherapy in combination with chemotherapy or pre- or postoperative radiotherapy)
- •Any other treatment
- •No clinical evidence of locoregional tumors or distant metastasis within 3 months after the completion of definitive treatment
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •WBC ≥ 3,500/mm^3 AND ≤ 12,000/mm^3
- •Neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •AST and ALT < 100 IU/L
- •Bilirubin < 1.5 mg/dL
- •Creatinine < 1.2 mg/dL
- •No uncontrolled cardiovascular disease
- •No interstitial pneumonia or pulmonary fibrosis
- •Must have sufficient oral intake
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent biologic therapy, radiotherapy, other chemotherapy, or any other therapy
排除标准
- 未提供
结局指标
主要结局
Disease-free survival
次要结局
- Relapse-free survival
- Adverse effects
- Overall survival