Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Functional Assessment of Cancer Therapy-Lung Questionaire（FACT-L）
研究概览
简要总结
The purpose of this study is to determine whether Low-frequency Rotating Magnetic Therapy System is effective and safe in the treatment of advanced lung cancer.
详细描述
The purpose of this study is to assess the efficacy and safety of the Low-frequency Rotating Magnetic Therapy System(with systemic anti-tumor therapy) compared to systemic anti-tumor therapy in patients suffering from advanced lung cancer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Willing and able to give written informed consent
- •Male or female aged 18 years and older
- •Histologic diagnosis of non-small cell lung cancer (unable to receive surgery) or small cell lung cancer (limited stage or extensive stage)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3- going to receive systemic anti-tumor therapy
- •Measurable disease based on RECIST 1.1
- •Adequate hematologic and organ function
排除标准
- •Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device
- •Unable to lie in bed
- •With any metal implants in body
- •Human immunodeficiency virus (HIV)
- •Malignancies other than lung cancer within 5 years prior to randomization
- •History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial or interfere with the subject's participation for the full duration of the trial
- •Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
研究组 & 干预措施
Sham control
Subjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization
干预措施: Systemic anti-tumor therapy (Drug)
Sham control
Subjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization
干预措施: Sham Low-frequency Rotating Magnetic Therapy System (Device)
Low-frequency Rotating Magnetic Therapy
Subjects will receive one cycle of treatment of low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization
干预措施: Low-frequency Rotating Magnetic Therapy System (Device)
Low-frequency Rotating Magnetic Therapy
Subjects will receive one cycle of treatment of low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization
干预措施: Systemic anti-tumor therapy (Drug)
结局指标
主要结局
Functional Assessment of Cancer Therapy-Lung Questionaire（FACT-L）
时间窗: within six weeks after randomization
Use the FACT-L to assess the effiency of low-frequency rotating magnetic system on the improvement of patients' quality of life
Number of Participants With Adverse Events That Are Related to Treatment
时间窗: From first time of study treatment until 90 days after the last, assessed up to 4 months
AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE 4.0\]
次要结局
- Duration of response according to standard RECIST v1.1(up to 5 years after the first patient randomized)
- Objective Response Rate (ORR)(up to 5 years after the first patient randomized)
- Progression Free Survival（PFS）(up to 5 years after the first patient randomized)
研究者
Chen Liang_An
Director of respiratory medicine
Chinese PLA General Hospital