An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- DFS (Disease free survival)
研究概览
简要总结
This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.
详细描述
It is confirmed by many studies that patients of thymoma with complete resection have better prognosis than those with either incomplete resection or without surgery. However,whether patients with stage II or III thymoma could benefit from adjuvant radiotherapy after complete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiotherapy after complete resection can improve survival for stage II or III thymoma.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed masaoka stage II or III thymoma; Have adequate bone marrow, hepatic, and renal function; Patients receive complete resection within 3 months; Written informed consent.
排除标准
- •Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.
研究组 & 干预措施
radiotherapy group
complete resection and adjuvant radiotherapy
干预措施: adjuvant radiotherapy (Radiation)
observation group
complete resection
结局指标
主要结局
DFS (Disease free survival)
时间窗: 5 years
from registration to disease progression or death.
次要结局
- OS(overall survival)(5 years)
- Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0(5 years)