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Microwave Ablation in Ground Glass Nodules

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ClinicalTrials.gov Identifier: NCT03490890
Recruitment Status : Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Xin Ye, Shandong Provincial Hospital

Brief Summary:
GGO was commonly observed recently.Radiofrequency ablation has been widely applied in the treatment of patients with GGO. No study had explored the microwave ablation in the treatment of GGO.

Condition or disease Intervention/treatment Phase
Microwave Ablation Lung Cancer Other: Microwave ablaton Phase 2

Detailed Description:
GGO was common with the development of image. Treatments of GGO include radical surgery and irradiation. For patients who were poor candidate of surgery, image guided thermal ablation could be an alternative.Radiofrequency ablation has been widely applied in the treatment of eary-stage non small cell lung cancer and those patients with GGO. However, up to date, no study had explored the microwave ablation in the treatment of GGO.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patient with GGO were treated with microwave ablation
Masking: None (Open Label)
Masking Description: All patient with GGO were treated with microwave ablation
Primary Purpose: Treatment
Official Title: Microwave Ablation in Ground Glass Nodules
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Microwave ablation in the GGO
Patients with GGO were treated with microwave ablation.
Other: Microwave ablaton
Patients with pathology verified GGO were treated with MWA.




Primary Outcome Measures :
  1. The survival of patients with GGO treated with MWA [ Time Frame: From the date of randomization until the date of the date of death from any cause, assessed up to 60 months ]
    The overall survival


Secondary Outcome Measures :
  1. The disease free survival of patients with GGO treated with MWA [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 60 months ]
    The disease free survival


Other Outcome Measures:
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
    The safety



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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:

  1. Patient has a histologically verified AIS or MIA.
  2. The tumors small enough to treat (usually ≤3 cm), and without chest pleura invasion.
  3. Solid cements in the GGO less than 50%.
  4. No other sites of disease observed.
  5. Patient is not a candidate for surgical removal of the cancer, or refused surgery.
  6. Patient is not a candidate for radiation therapy, or refused radiation therapy.
  7. Patient has > 6 month life expectancy.
  8. Eastern Cooperative Oncology Group performance status of 0 to 2.
  9. No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
  10. Sufficient organ functions.
  11. Written informed consent.

Exclusion Criteria:

  1. Active bacterial or fungous infection.
  2. Simultaneous or metachronous (within the past 5 years) double cancers.
  3. Women during pregnancy or breast-feeding.
  4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
  5. Uncontrollable diabetes mellitus. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

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): NCT03490890


Contacts
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Contact: Xin Ye +86 0531-68773172 yexintaian2014@163.com
Contact: Zhi g Wei +86 0531-68773171 weizhigang321321@163.com

Locations
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China, Shandong
Binzhou Medical University Hospital
Binzhou, Shandong, China, +86 256600
Dezhou People's Hospital
Dezhou, Shandong, China, +86 253000
The Second People's Hospital of Dezhou
Dezhou, Shandong, China, +86 253000
Jinan Military General Hospital
Jinan, Shandong, China, +83 250001
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, China, +86 250001
Shandong Provincial Hospital
Jinan, Shandong, China, +86 250001
Shandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, China, +86053168773172
Affliated Hospital of Jining Medical University
Jining, Shandong, China, +86 272000
Liaocheng Cancer Hospital
Liaocheng, Shandong, China, +86 252000
The People's Hospital of Pingyi Country
Linyi, Shandong, China, +86 276000
Affliated Hospital of Taishan Medical University
Taian, Shandong, China, +86 271000
The People's Liberation Army 88 Hospital
Taian, Shandong, China, +86 271000
Weifang People's Hospital
Weifang, Shandong, China, +86 262000
Yantai Yuhuangding Hospital
Yantai, Shandong, China, +86 264000
Tengzhou center of people's hospital
Zaozhuang, Shandong, China, +86 277000
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Study Director: Xin Ye Shandong Provincial Hospital

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Responsible Party: Xin Ye, Principal Investigator, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT03490890    
Other Study ID Numbers: Shandong PH JN
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xin Ye, Shandong Provincial Hospital:
microwave ablation
lung cancer
ground glass nodules
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors