A Phase II Study Examining the Feasibility of Long Term and Low Dose Oral Capecitabine (Xeloda®) in Newly Diagnosed Head and Neck Squamous Cell Carcinoma (HNSCC) After Surgery, Radiation and/or Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Compliance With Treatment .
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery, radiation therapy, and/or chemotherapy for head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery, radiotherapy, and/or chemotherapy.
Secondary
- Determine the time to recurrence, local-regional control, and survival rate in patients treated with this drug.
- Determine the incidence of second primary tumors in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Capecitabine
Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.
干预措施: capecitabine (Drug)
Capecitabine
Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.
干预措施: Surgery, chemotherapy and/or radiotherapy (Procedure)
结局指标
主要结局
Compliance With Treatment .
时间窗: within 365 days
Compliance is defined as taking at least 80% of the prescribed dose for one year.
次要结局
- Recurrence-free Survival(Within 3 years of end of study.)
- Overall Survival(Within 3 years of end of study)
- Incidence of Second Primary Tumors(Within 3 years of end of study)
研究者
George Yoo
Principal Investigator
Barbara Ann Karmanos Cancer Institute