Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection-Single Center Phase II Single Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.
详细描述
Adjuvant Radiotherapy(Postoperative radiotherapy) is proposed in stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.
Hypofractionation Radiotherapy is used in this study. The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thymoma and Thymic carcinoma confirmed by histology or cytology
- •R0 resection (complete resection)
- •stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.
- •Karnofsky performance status(KPS) 80, 90 or
- •Having sufficient Pulmonary function, renal function and liver function. Neutrophile granulocyte count>1.5×109 /L, platelet count>80×109 /L, hemoglobin ≥10g/dL.
排除标准
- •Prior thoracic radiotherapy.
- •Uncontrolled Comorbidities.
- •Pregnant or nursing mother.
- •Pneumonia
研究组 & 干预措施
Adjuvant Hypofractionation Radiotherapy
Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection
干预措施: Adjuvant Hypofractionation Radiotherapy (Radiation)
结局指标
主要结局
Disease Free Survival
时间窗: 2 years, 5 years
From the date of resection to the date of disease recurrence or death
次要结局
- Overall Survival(2 years, 5 years)
- RadiotherapyToxicity(1 years, 2 years, 5 years)
- local recurrence(2 years, 5 years)
- Intrathoracic recurrence / pleural metastasis(2 years, 5 years)
- metastasis free survival(2 years, 5 years)