Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.
详细描述
Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.
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
- •1.18~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.
排除标准
- •Distant metastases could not be encompassed within a tolerable radiotherapy field;
- •Underwent surgery, radiotherapy or chemotherapy before entering this study ;
- •Have other malignancy history excluding carcinoma in situ of cervix in the previous five years;
- •Active clinical pulmonary infection;
- •Pregnant or nursing.
结局指标
主要结局
Objective response rate
时间窗: 3 months after treatment
Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria
次要结局
- Overall survival(2 years)
- Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0(up to 2 years)
- Progression free survival(2 years)