A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma
概览
- 阶段
- 3 期
- 干预措施
- radiotherapy
- 疾病 / 适应症
- Thymoma and Thymic Carcinoma
- 发起方
- Fudan University
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Progression free survival
- 状态
- 撤回
- 最后更新
- 5天前
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.
研究者
入排标准
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
radiotherapy
adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)
干预措施: radiotherapy
Radiochemotherapy
adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
干预措施: Cisplatin
Radiochemotherapy
adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
干预措施: Etoposide
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)