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

Stage I NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02896166
• Other study ID #: Shandong Provincial Hospital
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 20, 2016
• Last updated: June 13, 2017
• Start date: September 2016
• Est. completion date: September 2019

Study information

• Verified date: June 2017
• Source: Shandong Provincial Hospital
• Contact: Xin Ye, M.D
• Phone: +8615168887755
• Email: yexintaian2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Stage I NSCLC

Intervention

Other:
• microwave ablation
eligible patients will be treated with microwave ablation in the primary tumor sites

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong
China	Shandong Provincial Hospital affliated to Shandong University	Jinan	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	1-,2-, and 3-year survival rate		From the time of randomization to the end of 1-,2-, and 3-year,respectively
Primary	Overall survival		From the date of randomization until the date of death from any cause,assessed up to 36 months
Secondary	Disease free survival		From the date of randomization until the date of first documented progression,assessed up to 36 months