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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-09-30

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.

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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.

Conditions

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Stage I NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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microwave ablation

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.

Group Type EXPERIMENTAL

microwave ablation

Intervention Type OTHER

eligible patients will be treated with microwave ablation in the primary tumor sites

Interventions

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microwave ablation

eligible patients will be treated with microwave ablation in the primary tumor sites

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient has a histologically or cytologically verified NSCLC,
2. The tumors small enough to treat (usually \<4 cm), and without chest pleura invasion.
3. Clinical stage I NSCLC with no other sites of disease,.
4. Patient is not a candidate for surgical removal of the cancer, or refused surgery.
5. Patient is not a candidate for radiation therapy, or refused radiation therapy.
6. Patient has \> 6 month life expectancy.
7. Eastern Cooperative Oncology Group performance status of 0 to 2.
8. No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
9. Sufficient organ functions.
10. 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.
6. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No