Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 6
- 主要终点
- Difference in quality of life
研究概览
简要总结
The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.
详细描述
Primary objective: To assess whether the addition of radiotherapy to the remaining thoracic tumor burden following standard medical treatment results in a superior quality of life measured with lung cancer symptom scale (LCSS) in patients with stage IV non-small cell lung cancer. The comparison will be made at three months after randomization.
Secondary objectives: Overall survival, progression-free survival, toxicity and longitudinal quality of life measurements.
Design: Multicentre, randomized, phase III trial. Patients will be registered for the study up-front but randomization will be performed after evaluation of response, three months after initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy. Randomization will be to thoracic radiotherapy or follow-up (1:1).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmed non-small cell lung cancer (NSCLC)
- •Stage IV disease
- •Previously untreated disease (before first line treatment)
- •No symptomatic brain metastases
- •Performance status (WHO) 0-2
- •FEV1 (forced expiratory volume one second) ≥ 1 L or >40% of predicted
- •Written informed consent
- •Life expectancy ≥ 12 weeks
- •Platelet count ≥ 100,00/mm3
- •Hemoglobin ≥ 10 g/dl
- •WBC (White blod cells) ≥ 3,000/mm3
- •Kidney function allowing chemotherapy
- •Patients scheduled for standard platinum based chemotherapy, chemo-immunotherapy or immunotherapy
- •Willing and able to comply with study treatment
排除标准
- •Requirement for daily supplemental oxygen
- •Second primary malignancy within 3 years, except for any of the following which can be included even if diagnosed within the past 3 years: Carcinoma in situ of the cervix, nonmelanoma skin cancer, history of low-grade (Gleason score ≤ 6) localized prostate cancer, definitely treated stage I breast cancer, other malignancy that was diagnosed and definitely treated ≥ 3 years ago with no subsequent evidence of recurrence
- •Concurrent severe and/or uncontrolled medical condition, including any of the following:
- •Angina pectoris
- •Congestive heart failure within the past 3 months, unless LVEF (left ventricular ejection fraction) > 40%
- •Myocardial infarction within the past 6 months
- •Clinically significant infection
- •Psychiatric illness or social situation that would limit compliance with study requirements
- •EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinas) - rearrangement detected
结局指标
主要结局
Difference in quality of life
时间窗: Three months after randomization
LCSS, lung cancer symptom scale. A scale from zero to one-hundred, higher number indicate worse symptoms.
次要结局
- Overall survival(24 months)
- Progression free survival(24 months)
- Toxicity of esophagitis, pneumonitis, dyspnea, fatigue, cough(During follow-up , up to 24 months.)
研究者
Ass. Prof. Jan Nyman
Head of Swedish Lung Cancer Study Group, Ass. Prof.
Swedish Lung Cancer Study Group