Microwave Ablation in Ground Glass Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Microwave Ablation in Ground Glass Nodules

Conditions
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Microwave Ablation, Lung Cancer

Intervention / Treatment
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* Other: Microwave ablaton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patient with GGO were treated with microwave ablation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microwave ablation in the GGO<br>Patients with GGO were treated with microwave ablation. | Other: Microwave ablaton<br>* Patients with pathology verified GGO were treated with MWA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The disease free survival of patients with GGO treated with MWA | The disease free survival | From date of randomization until the date of first documented progression, assessed up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microwave ablation, lung cancer, ground glass nodules