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

June 13, 2017 updated by: Xin Ye, Shandong Provincial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, +86 250001
        • Shandong Provincial Hospital
      • Jinan, Shandong, China, +86053168773172
        • Shandong Provincial Hospital affliated to Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: From the date of randomization until the date of death from any cause，assessed up to 36 months
From the date of randomization until the date of death from any cause，assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: From the date of randomization until the date of first documented progression，assessed up to 36 months
From the date of randomization until the date of first documented progression，assessed up to 36 months

Other Outcome Measures

Outcome Measure
Time Frame
1-,2-, and 3-year survival rate
Time Frame: From the time of randomization to the end of 1-,2-, and 3-year,respectively
From the time of randomization to the end of 1-,2-, and 3-year,respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

August 20, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shandong Provincial Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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