Microwave Ablation in Ground Glass Nodules

April 6, 2018 updated by: Xin Ye, Shandong Provincial Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the date of randomization until the date of the date of death from any cause, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the date of first documented progression, assessed up to 60 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Investigators

  • Study Director: Xin Ye, Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shandong PH JN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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