MedPath

Microwave Ablation in Ground Glass Nodules

Phase 2
Not yet recruiting
Conditions
Microwave Ablation
Lung Cancer
Interventions
Other: Microwave ablaton
Registration Number
NCT03490890
Lead Sponsor
Shandong Provincial Hospital
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
200
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Microwave ablation in the GGOMicrowave ablatonPatients with GGO were treated with microwave ablation.
Primary Outcome Measures
NameTimeMethod
The survival of patients with GGO treated with MWAFrom the date of randomization until the date of the date of death from any cause, assessed up to 60 months

The overall survival

Secondary Outcome Measures
NameTimeMethod
The disease free survival of patients with GGO treated with MWAFrom date of randomization until the date of first documented progression, assessed up to 60 months

The disease free survival

Trial Locations

Locations (15)

Liaocheng Cancer Hospital

πŸ‡¨πŸ‡³

Liaocheng, Shandong, China

Affliated Hospital of Taishan Medical University

πŸ‡¨πŸ‡³

Taian, Shandong, China

Yantai Yuhuangding Hospital

πŸ‡¨πŸ‡³

Yantai, Shandong, China

Tengzhou center of people's hospital

πŸ‡¨πŸ‡³

Zaozhuang, Shandong, China

The People's Hospital of Pingyi Country

πŸ‡¨πŸ‡³

Linyi, Shandong, China

The People's Liberation Army 88 Hospital

πŸ‡¨πŸ‡³

Taian, Shandong, China

Weifang People's Hospital

πŸ‡¨πŸ‡³

Weifang, Shandong, China

Affliated Hospital of Shandong Academy of Medical Sciences

πŸ‡¨πŸ‡³

Jinan, Shandong, China

Shandong Provincial Hospital

πŸ‡¨πŸ‡³

Jinan, Shandong, China

Affliated Hospital of Jining Medical University

πŸ‡¨πŸ‡³

Jining, Shandong, China

Binzhou Medical University Hospital

πŸ‡¨πŸ‡³

Binzhou, Shandong, China

Dezhou People's Hospital

πŸ‡¨πŸ‡³

Dezhou, Shandong, China

The Second People's Hospital of Dezhou

πŸ‡¨πŸ‡³

Dezhou, Shandong, China

Jinan Military General Hospital

πŸ‡¨πŸ‡³

Jinan, Shandong, China

Shandong Provincial Hospital affliated to Shandong University

πŸ‡¨πŸ‡³

Jinan, Shandong, China

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