A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.
详细描述
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 thymoma or thymic carcinoma.However,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.
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
- Single (Investigator)
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 ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete 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
Radiochemotherapy
adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
干预措施: radiotherapy (Radiation)
radiotherapy
adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)
干预措施: radiotherapy (Radiation)
Radiochemotherapy
adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
干预措施: Cisplatin (Drug)
Radiochemotherapy
adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
干预措施: Etoposide (Drug)
结局指标
主要结局
Progression free survival
时间窗: 2 years
from registration to disease progression or death.
次要结局
- Overall survival(2 years)
- Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0(2 years)