Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer Using Hypofractionated Technique.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.
详细描述
This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.
- For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
- For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
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
- •loco-regionally recurrent NSCLC after thoracic radiotherapy (confirmed by pathology or continuous enhanced CT imaging);
- •chemotherapy, targeted or immunotherapy are allowed before enrollment;
- •>=6 months from previous chest radiotherapy;
- •presence of measurable disease according to RECIST criteria;
- •ECOG performance score is 0-1;
- •organ and bone marrow functions meet the following criteria:
- •forced expiratory volume in 1 second (FEV1) ≥ 0.8L;
- •percentage-predicted single-breath carbon monoxide diffusing capacity (DLCO %) > 60%;
- •absolute neutrophil count ≥1.5×10^9/L;
- •platelet ≥80×10^9/L;
- •hemoglobin ≥9.0g/dL;
- •serum creatinine clearance was ≥50 mL/min calculated based on the Cockcroft-Gault formula
- •serum bilirubin ≤1.5 times normal upper limit (ULN)
- •AST and ALT≤2.5 times ULN
排除标准
- •previous or concurrent with other malignant tumors, except for non-melanoma of the skin or carcinoma in situ of the cervix;
- •loco-regional recurrence with distant metastasis;
- •any other disease or condition contradicted to radiotherapy (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
- •women who are pregnant or breastfeeding, women who have not undergone a pregnancy test (within 14 days before first administration), and women who are pregnant;
- •pregnancy, lactation, or fertility but no contraceptive measures;
- •those with bleeding tendency;
- •participate in other clinical trials within 30 days before enrollment;
- •drug and other drug addiction, chronic alcoholism and AIDS patients;
- •having uncontrollable seizures or loss of self-control due to psychosis;
- •a history of severe allergies;
- •participants considered unfit to participate in this study.
研究组 & 干预措施
thoracic irradiation
For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
干预措施: thoracic irradiation (Radiation)
thoracic irradiation
For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
干预措施: Concurrent chemotherapy (Drug)
结局指标
主要结局
Overall Survival
时间窗: 2 years
次要结局
- Local Control(2 Years)
- Incidence of Grade ≥3 pulmonary toxicity/esophageal toxicity(1 Year)
研究者
Hui Liu
Professor
Sun Yat-sen University