Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery, and some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse surgery. For those patients, microwave ablation (MWA) could be an alternative treatment. Several small sample retrospective studies verified that MWA could be an efficacy and safe treatment.

Detailed Description
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Patients with stage I non small cell lung cancer unfit for or refused surgery will be treated with MWA in the primary tumor sites.

Official Title
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Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer

Conditions
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Stage I NSCLC

Intervention / Treatment
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* Other: microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a histologically or cytologically verified NSCLC, The tumors small enough to treat (usually <4 cm), and without chest pleura invasion. Clinical stage I NSCLC with no other sites of disease,. 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microwave ablation<br>The procedure is performed similar to a needle biopsy of the lung, under CT guidance. Placement of the needle-electrode is similar to needle placement for CT-guided biopsy. Appropriate positioning of the microwave ablation antenna is confirmed by CT imaging. | Other: microwave ablation<br>* eligible patients will be treated with microwave ablation in the primary tumor sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | From the date of randomization until the date of death from any cause，assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | From the date of randomization until the date of first documented progression，assessed up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nsclc and stage I and microwave ablation