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

• Sponsor: Shandong Provincial Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02896166
• Collaborator: (none)
• Enrollment: 150
• Locations: 2
• Arm: 1
• Duration (Months): 36
• Patients Per Site: 75
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stage I NSCLC	Other: microwave ablation	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer
• Study Start Date: Sep 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2019
• Anticipated Study Completion Date: Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: microwave ablation The procedure is performed similar to a needle biopsy of the lung, under CT guidance. Placement of the needle-electrode is similar to needle placement for CT-guided biopsy. Appropriate positioning of the microwave ablation antenna is confirmed by CT imaging.	Other: microwave ablation; eligible patients will be treated with microwave ablation in the primary tumor sites

Outcome Measures

Primary Outcome Measures

1. Overall survival [From the date of randomization until the date of death from any cause，assessed up to 36 months]

Secondary Outcome Measures

1. Disease free survival [From the date of randomization until the date of first documented progression，assessed up to 36 months]

Other Outcome Measures

1. 1-,2-, and 3-year survival rate [From the time of randomization to the end of 1-,2-, and 3-year,respectively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Provincial Hospital	Jinan	Shandong	China	[phone]
2	Shandong Provincial Hospital affliated to Shandong University	Jinan	Shandong	China	[phone]

Sponsors and Collaborators

• Shandong Provincial Hospital

Investigators

• Principal Investigator: Xin Ye, M.D., Shandong Provincial Hospital affliated to Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xin Ye, Shandong Provincial Hospital affliated to Shandong University, Shandong Provincial Hospital
• ClinicalTrials.gov Identifier: NCT02896166
• Other Study ID Numbers: Shandong Provincial Hospital
• First Posted: Sep 12, 2016
• Last Update Posted: Jun 14, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Xin Ye, Shandong Provincial Hospital affliated to Shandong University, Shandong Provincial Hospital: nsclc and stage I and microwave ablation
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jun 14, 2017