Microwave Ablation in Ground Glass Nodules
1 other identifier
interventional
200
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2018
Longer than P75 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2018
CompletedFirst Posted
Study publicly available on registry
April 6, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedApril 9, 2018
April 1, 2018
2 years
March 26, 2018
April 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The survival of patients with GGO treated with MWA
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 Outcomes (1)
The disease free survival of patients with GGO treated with MWA
From date of randomization until the date of first documented progression, assessed up to 60 months
Other Outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 year
Study Arms (1)
Microwave ablation in the GGO
EXPERIMENTALPatients with GGO were treated with microwave ablation.
Interventions
Patients with pathology verified GGO were treated with MWA.
Eligibility Criteria
You may qualify if:
- Patient has a histologically verified AIS or MIA.
- The tumors small enough to treat (usually ≤3 cm), and without chest pleura invasion.
- Solid cements in the GGO less than 50%.
- No other sites of disease observed.
- Patient is not a candidate for surgical removal of the cancer, or refused surgery.
- Patient is not a candidate for radiation therapy, or refused radiation therapy.
- Patient has \> 6 month life expectancy.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
- Sufficient organ functions.
- Written informed consent.
You may not qualify if:
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Women during pregnancy or breast-feeding.
- Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Binzhou Medical University Hospital
Binzhou, Shandong, +86 256600, China
Dezhou People's Hospital
Dezhou, Shandong, +86 253000, China
The Second People's Hospital of Dezhou
Dezhou, Shandong, +86 253000, China
Jinan Military General Hospital
Jinan, Shandong, +83 250001, China
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, +86 250001, China
Shandong Provincial Hospital
Jinan, Shandong, +86 250001, China
Shandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, +86053168773172, China
Affliated Hospital of Jining Medical University
Jining, Shandong, +86 272000, China
Liaocheng Cancer Hospital
Liaocheng, Shandong, +86 252000, China
The People's Hospital of Pingyi Country
Linyi, Shandong, +86 276000, China
Affliated Hospital of Taishan Medical University
Taian, Shandong, +86 271000, China
The People's Liberation Army 88 Hospital
Taian, Shandong, +86 271000, China
Weifang People's Hospital
Weifang, Shandong, +86 262000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, +86 264000, China
Tengzhou center of people's hospital
Zaozhuang, Shandong, +86 277000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xin Ye
Shandong Provincial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All patient with GGO were treated with microwave ablation
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2018
First Posted
April 6, 2018
Study Start
May 1, 2018
Primary Completion
April 30, 2020
Study Completion
April 30, 2025
Last Updated
April 9, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share