Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- grade 2 or more pneumonitis
研究概览
简要总结
The aim of this randomized study is to investigate pneumonitis, local tumor control, and survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC responded to immunotherapy and chemotherapy
详细描述
Studies have confirmed that systemic therapy combined with primary tumor radiotherapy can improve symptoms and prolong survival of advanced NSCLC. Our previous sturdy indicated that patients who received immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis. Patients suffered grade 2 or more pneumonitis have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting primary tumor CTV radiation therapy showed no reduction in local control and survival for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC);
- •After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
- •Age 18 to 80 years old, performance status 0-1;
- •measurable or evaluable lesions;
- •Survival expectancy is not less than 6 months;
- •adequate cardiac, pulmonary, renal, and hepatic and bone marrow function
排除标准
- •tumor progress after therapy with immunotherapy and chemotherapy
- •EGFR, ALK, or ROS1 mutation;
- •Previous thoracic radiotherapy;
- •grade 2 or more immune-related adverse events after induction immunotherapy
- •Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);
- •Pregnant or lactating women
- •undergoing other clinical trials;
- •Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;
- •Patients with HIV positive and undergoing antiviral therapy;
- •Active tuberculosis
结局指标
主要结局
grade 2 or more pneumonitis
时间窗: up to 6 months
次要结局
- grade 3 or more pneumonitis(up to 6 months)
- Progress free survival(up to 12 months)
- grade 3 or more esophagitis(up to 6 months)
- local/regional control rate(up to 12 months)
研究者
HAN GUANG
Director of the department of Radiotherapy Oncology
Hubei Cancer Hospital