Microwave Ablation in Ground Glass Nodules

Lung Cancer Clinical Trial

Official title:

Microwave Ablation in Ground Glass Nodules

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03490890
• Other study ID #: Shandong PH JN
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 26, 2018
• Last updated: April 6, 2018
• Start date: May 1, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2018
• Source: Shandong Provincial Hospital
• Contact: Xin Ye
• Phone: +86 0531-68773172
• Email: yexintaian2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Microwave Ablation

Intervention

Other:
• Microwave ablaton
Patients with pathology verified GGO were treated with MWA.

Locations

Country	Name	City	State
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Dezhou People's Hospital	Dezhou	Shandong
China	The Second People's Hospital of Dezhou	Dezhou	Shandong
China	Affliated Hospital of Shandong Academy of Medical Sciences	Jinan	Shandong
China	Jinan Military General Hospital	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Shandong Provincial Hospital affliated to Shandong University	Jinan	Shandong
China	Affliated Hospital of Jining Medical University	Jining	Shandong
China	Liaocheng Cancer Hospital	Liaocheng	Shandong
China	The People's Hospital of Pingyi Country	Linyi	Shandong
China	Affliated Hospital of Taishan Medical University	Taian	Shandong
China	The People's Liberation Army 88 Hospital	Taian	Shandong
China	Weifang People's Hospital	Weifang	Shandong
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Tengzhou center of people's hospital	Zaozhuang	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	The safety	1 year
Primary	The survival of patients with GGO treated with MWA	The overall survival	From the date of randomization until the date of the date of death from any cause, assessed up to 60 months
Secondary	The disease free survival of patients with GGO treated with MWA	The disease free survival	From date of randomization until the date of first documented progression, assessed up to 60 months