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

Primary Purpose

Stage I NSCLC

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
microwave ablation
Sponsored by
Shandong Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I NSCLC focused on measuring nsclc and stage I and microwave ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shandong Provincial Hospital
  • Shandong Provincial Hospital affliated to Shandong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

microwave ablation

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Disease free survival

Full Information

First Posted
August 20, 2016
Last Updated
June 13, 2017
Sponsor
Shandong Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02896166
Brief Title
Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer
Official Title
Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I NSCLC
Keywords
nsclc and stage I and microwave ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
microwave ablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
microwave ablation
Intervention Description
eligible patients will be treated with microwave ablation in the primary tumor sites
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
From the date of randomization until the date of death from any cause，assessed up to 36 months
Secondary Outcome Measure Information:
Title
Disease free survival
Time Frame
From the date of randomization until the date of first documented progression，assessed up to 36 months
Other Pre-specified Outcome Measures:
Title
1-,2-, and 3-year survival rate
Time Frame
From the time of randomization to the end of 1-,2-, and 3-year,respectively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has a histologically or cytologically verified NSCLC, The tumors small enough to treat (usually <4 cm), and without chest pleura invasion. Clinical stage I NSCLC with no other sites of disease,. 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 2. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Ye, M.D
Phone
+8615168887755
Email
yexintaian2014@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
gang Z Wei, M.D.
Phone
+8618615287195
Email
weizhigang321321@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Ye, M.D.
Organizational Affiliation
Shandong Provincial Hospital affliated to Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
+86 250001
Country
China
Facility Name
Shandong Provincial Hospital affliated to Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
+86053168773172
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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