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Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02701231
Recruitment Status : Unknown
Verified March 2016 by Chen Liang_An, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : March 8, 2016
Last Update Posted : March 9, 2016
Sponsor:
Collaborators:
Xijing Hospital
Shandong University of Traditional Chinese Medicine
Shandong Provincial Hospital
Information provided by (Responsible Party):
Chen Liang_An, 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.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Device: Low-frequency Rotating Magnetic Therapy System Drug: Systemic anti-tumor therapy Device: Sham Low-frequency Rotating Magnetic Therapy System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham control
Subjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization
Drug: Systemic anti-tumor therapy
Systemic anti-tumor therapy includes targeted therapies, chemotherapy and best supportive care, according to NCCN non-small cell lung cancer(NSCLC) and small cell lung cancer(SCLC) guidelines. SCLC patients will receive six cycles of cisplatin and etoposide. NSCLC patients will receive EGFR and ALK test. With sensitive result the first-line therapy will be Erlotinib/Gefitinib/Crizotinib. If insensitive, the patient will receive six cycles of cisplatin and pemetrexed. Then the patient will receive tumor response evaluation. The patient with response or stable disease will receive maintenance therapy with one or some of the drugs including bevacizumab, pemetrexed, gemcitabine and docetaxel until disease progression. During experience all patients will receive clinical observation. Once proven for disease progression the patient will finish the experiment.
Other Name: Systemic therapies for advanced lung cancer

Device: Sham Low-frequency Rotating Magnetic Therapy System
Sham Low-frequency Rotating Magnetic Therapy System is a similar apparatus except that there were two rotating iron plates instead of magnets, thus lacking a magnetic field.

Experimental: 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
Device: Low-frequency Rotating Magnetic Therapy System
Two pairs of fan-shaped NdFeB permanent magnets were attached to a circular iron plate and arranged to establish magnetic field. The bottom two magnets rotated at certain frequency driven by a step motor, which was controlled using a functional signal generator. The top two magnets rotated synchronously due to the strong magnetic interaction. Magnetic flux density was measured at the target site using a gauss meter. The entire magnetic apparatus was located in a hood with humidity and temperature controller.

Drug: Systemic anti-tumor therapy
Systemic anti-tumor therapy includes targeted therapies, chemotherapy and best supportive care, according to NCCN non-small cell lung cancer(NSCLC) and small cell lung cancer(SCLC) guidelines. SCLC patients will receive six cycles of cisplatin and etoposide. NSCLC patients will receive EGFR and ALK test. With sensitive result the first-line therapy will be Erlotinib/Gefitinib/Crizotinib. If insensitive, the patient will receive six cycles of cisplatin and pemetrexed. Then the patient will receive tumor response evaluation. The patient with response or stable disease will receive maintenance therapy with one or some of the drugs including bevacizumab, pemetrexed, gemcitabine and docetaxel until disease progression. During experience all patients will receive clinical observation. Once proven for disease progression the patient will finish the experiment.
Other Name: Systemic therapies for advanced lung cancer




Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy-Lung Questionaire(FACT-L) [ Time Frame: 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

  2. Number of Participants With Adverse Events That Are Related to Treatment [ Time Frame: 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 :
  1. Duration of response according to standard RECIST v1.1 [ Time Frame: 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.

  2. Objective Response Rate (ORR) [ Time Frame: 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 .

  3. Progression Free Survival(PFS) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701231


Contacts
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Contact: Liang_an Chen, MD, phD 8610-55499027 chenla301@263.net

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Liang-An Chen, MD, phD    8610-55499027    chenla301@263.net   
Principal Investigator: Liang-An Chen, MD, phD         
China, Shandong
Affiliated hospital of Shandong University of traditional Chinese medicine Not yet recruiting
Jinan, Shandong, China, 250011
Shandong Provincial Hospital Not yet recruiting
Jinan, Shandong, China, 250021
China, Shanxi
Xijing Hospital affiliated to the Fourth Military Medical University Not yet recruiting
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Chinese PLA General Hospital
Xijing Hospital
Shandong University of Traditional Chinese Medicine
Shandong Provincial Hospital
Investigators
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Principal Investigator: Liang_an Chen, MD, phD Chinese PLA General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chen Liang_An, Director of respiratory medicine, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02701231    
Other Study ID Numbers: S2015-093-01
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Because of personal privacy, the research-related individual participant data do not intend for public sharing.
Keywords provided by Chen Liang_An, Chinese PLA General Hospital:
lung cancer
Low-frequency rotating magnetic therapy system
systemic anti-tumor therapy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases