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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02701231
• Other study ID #: S2015-093-01
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2016
• Last updated: March 8, 2016
• Start date: November 2015
• Est. completion date: December 2020

Study information

• Verified date: March 2016
• Source: Chinese PLA General Hospital
• Contact: Liang_an Chen, MD, phD
• Phone: 8610-55499027
• Email: chenla301[@]263.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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.

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Affiliated hospital of Shandong University of traditional Chinese medicine	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Xijing Hospital affiliated to the Fourth Military Medical University	Xi'an	Shanxi

Sponsors (4)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Shandong Provincial Hospital, Shandong University of Traditional Chinese Medicine, Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy-Lung Questionaire(FACT-L)	Use the FACT-L to assess the effiency of low-frequency rotating magnetic system on the improvement of patients' quality of life	within six weeks after randomization	No
Primary	Number of Participants With Adverse Events That Are Related to Treatment	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]	From first time of study treatment until 90 days after the last, assessed up to 4 months	Yes
Secondary	Duration of response according to standard RECIST v1.1	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.	up to 5 years after the first patient randomized	No
Secondary	Objective Response Rate (ORR)	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 .	up to 5 years after the first patient randomized	No
Secondary	Progression Free Survival(PFS)	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.	up to 5 years after the first patient randomized	No