Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- therapeutic success
研究概览
简要总结
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
详细描述
To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma
排除标准
- •A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions,supposed to live less than 6 months.
结局指标
主要结局
therapeutic success
时间窗: From date of treatment until the date of completing treatment 1 month later
A combined primary end point, named "therapeutic success"(TS), was used; it took into account activity, toxicity, and compliance.A TS was defined as a patient completing radiotherapy at the planned dose and schedule (no re-treatment delays beyond 2 weeks), and having an objective response (either complete or partial based on RECIST criteria) without (1) grade 3-4 nonhematological toxicity, (2) complications associated with hematologic toxicity such as febrile neutropenia, infection, bleeding, or transfusion, or (3) any toxicity leading to hospitalization or death.
次要结局
未报告次要终点