Microwave Ablation in Ground Glass Nodules
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Shandong Provincial Hospital
- Enrollment
- 200
- Locations
- 15
- Primary Endpoint
- The survival of patients with GGO treated with MWA
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
All patient with GGO were treated with microwave ablation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Microwave ablation in the GGO
Patients with GGO were treated with microwave ablation.
Intervention: Microwave ablaton (Other)
Outcomes
Primary Outcomes
The survival of patients with GGO treated with MWA
Time Frame: From the date of randomization until the date of the date of death from any cause, assessed up to 60 months
The overall survival
Secondary Outcomes
- The disease free survival of patients with GGO treated with MWA(From date of randomization until the date of first documented progression, assessed up to 60 months)
Investigators
Xin Ye
Principal Investigator
Shandong Provincial Hospital