Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer
- Conditions
- Lung Neoplasms
- Interventions
- Drug: Systemic anti-tumor therapyDevice: Low-frequency Rotating Magnetic Therapy SystemDevice: Sham Low-frequency Rotating Magnetic Therapy System
- Registration Number
- NCT02701231
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham control Systemic anti-tumor therapy Subjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization Sham control Sham Low-frequency Rotating Magnetic Therapy System Subjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization Low-frequency Rotating Magnetic Therapy Low-frequency Rotating Magnetic Therapy System Subjects will receive one cycle of treatment of low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization Low-frequency Rotating Magnetic Therapy Systemic anti-tumor therapy Subjects will receive one cycle of treatment of low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization
- Primary Outcome Measures
Name Time Method Functional Assessment of Cancer Therapy-Lung Questionaire（FACT-L） 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 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 \[CTCAE 4.0\]
- Secondary Outcome Measures
Name Time Method Duration of response according to standard RECIST v1.1 up to 5 years after the first patient randomized At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Duration of response: the time from the first documentation of CR or PR or SD to objective disease progression (PD) or death from any cause.
Objective Response Rate (ORR) up to 5 years after the first patient randomized At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Objective response rate: the percentage of subjects who have at least one visit response of CR or PR prior to any evidence of progression .
Progression Free Survival（PFS） up to 5 years after the first patient randomized At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Progression Free Survival (PFS) : the time from start of study treatment to the first documentation of objective disease progression (PD) or death from any cause.
Trial Locations
- Locations (4)
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Xijing Hospital affiliated to the Fourth Military Medical University
🇨🇳Xi'an, Shanxi, China
Affiliated hospital of Shandong University of traditional Chinese medicine
🇨🇳Jinan, Shandong, China