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

Phase 3

• Conditions: Stage I NSCLC
• Interventions: Other: microwave ablation

• Registration Number: NCT02896166
• Lead Sponsor: Shandong Provincial Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2016-08-20
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
microwave ablation	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	From the date of randomization until the date of death from any cause，assessed up to 36 months

Secondary Outcome Measures

Name	Time	Method
Disease free survival	From the date of randomization until the date of first documented progression，assessed up to 36 months

Trial Locations

Locations (2)

Shandong Provincial Hospital affliated to Shandong University; 🇨🇳 Jinan, Shandong, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China