Spleen Radiotherapy Decreases Severe Chemotherapy Induced Thrombocytopenia (CIT) for the Multi-center Randomized Controlled Study in Advanced NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- The incidence of severe CIT afer chemotherapy
研究概览
简要总结
Chemotherapy is one of the main treatments for advanced NSCLC. However, chemotherapy induced thrombocytopenia (CIT) is one of the most important limitations for subsequent chemotherapy of cancer.
Although platelet transfusion is the gold standard to treat severe CIT, its clinical application is limited due to many disadvantages, such as short time for storage, not easy to save, the risk of infection and immunological diseases. What's more, other cytokines including IL-11 and rhTPO, are not so useful in clinical work. It is necessary to explore a new therapeutic method to treat CIT.
Researches show that spleen resection could improve the count of PLT. In this clinical trial, we design chemotherapy plus spleen radiotherapy to the subjects with advanced NSCLC, simultaneously, who underwent grade II or worse CIT. The primary endpoint is the incidence of severe CIT (≧grade III) in subsequent chemotherapy, the second endpoints are recovery time from bone marrow suppression and progression free survival, and the exploring index is the immulogical status.
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
- •Patients with advanced (Stage IIIA or IIIB AJCC 7) NSCLC that was histologically or cytologically inoperable
- •ECOG whole body status (performancestatus,PS) level 0 or 1
- •The estimated survival time is more than 12 weeks, 18 ~75 years old
- •Laboratory results within 2 weeks prior to radiotherapy met the following criteria: ① Neutrophil count > 1,500/ MCL Heathko-Pilot Oncology Research Fund; ② Platelet > 50,000/ MCL; ③ Total bilirubin < 1.5 times of the normal upper limit value; ④AST(SGOT)/ALT(SGPT) < 2.5 times of the normal upper limit; ⑤ Serum creatinine < 1.5 times of the normal upper limit value; ⑥ The results of coagulation function examination were within the normal range
- •Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug
- •Understand and voluntarily sign written informed consent
- •The investigator judged that the patient had good compliance
排除标准
- •Patients with serious functional damage of important organs;
- •Patients diagnosed adequately with other malignant tumors;
- •Pregnant or lactating women;
- •Patients in an active period of acute or chronic infectious diseases;
- •Combined with the disease of connective tissue
- •Patients who are allergic to any drugs or people with allergies;
- •Patients who participate in other clinical trials concurrently;
- •Brain metastases without being controlled;
- •With immunologic thrombocytopenia；
- •Excluding thrombocytopenia caused by other reasons(Non chemotherapeutic agents, such as heparin, etc.);
- •The degree of tumor thrombus >2;
- •Patients who are considered not eligible for the trial after evaluation by investigator.
结局指标
主要结局
The incidence of severe CIT afer chemotherapy
时间窗: 18 weeks after randomization
次要结局
- Recovery time after severe bone marrow suppression(18 weeks after randomization)
- Progression free suvival (PFS)(Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months)
- Objective response rate (ORR)(Time Frame: 18 weeks after randomization)
研究者
Jianguo Sun
Deputy director,Xinqiao Hospital of Chongqing
Xinqiao Hospital of Chongqing