Clinical trial NCT03490890: Microwave Ablation in Ground Glass Nodules
Official title: Microwave Ablation in Ground Glass Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Microwave Ablation
Lung Cancer
Keywords: microwave ablation
lung cancer
ground glass nodules
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2018-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patient with GGO were treated with microwave ablation
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patient has a histologically verified AIS or MIA.
2. The tumors small enough to treat (usually ≤3 cm), and without chest pleura invasion.
3. Solid cements in the GGO less than 50%.
4. No other sites of disease observed.
5. Patient is not a candidate for surgical removal of the cancer, or refused surgery.
6. Patient is not a candidate for radiation therapy, or refused radiation therapy.
7. Patient has \> 6 month life expectancy.
8. Eastern Cooperative Oncology Group performance status of 0 to 2.
9. No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
10. Sufficient organ functions.
11. 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. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Primary outcomes:
measure: The survival of patients with GGO treated with MWA
timeFrame: From the date of randomization until the date of the date of death from any cause, assessed up to 60 months
Secondary outcomes:
measure: The disease free survival of patients with GGO treated with MWA
timeFrame: From date of randomization until the date of first documented progression, assessed up to 60 months
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 year
Locations:
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Dezhou
country: China
facility: Dezhou People's Hospital
state: Shandong
city: Dezhou
country: China
facility: The Second People's Hospital of Dezhou
state: Shandong
city: Jinan
country: China
facility: Jinan Military General Hospital
state: Shandong
city: Jinan
country: China
facility: Affliated Hospital of Shandong Academy of Medical Sciences
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital affliated to Shandong University
state: Shandong
city: Jining
country: China
facility: Affliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng Cancer Hospital
state: Shandong
city: Linyi
country: China
facility: The People's Hospital of Pingyi Country
state: Shandong
city: Taian
country: China
facility: Affliated Hospital of Taishan Medical University
state: Shandong
city: Taian
country: China
facility: The People's Liberation Army 88 Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Tengzhou center of people's hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Xin Ye
role: STUDY_DIRECTOR
References: