NCT02896166

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2016

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

August 20, 2016

Last Update Submit

June 13, 2017

Conditions

Stage I NSCLC

Keywords

nsclc and stage I and microwave ablation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    From the date of randomization until the date of death from any cause，assessed up to 36 months

Secondary Outcomes (1)

  • Disease free survival

    From the date of randomization until the date of first documented progression，assessed up to 36 months

Other Outcomes (1)

  • 1-,2-, and 3-year survival rate

    From the time of randomization to the end of 1-,2-, and 3-year,respectively

Study Arms (1)

microwave ablation

EXPERIMENTAL

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

Interventions

microwave ablationOTHER

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

microwave ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shandong Provincial Hospital

Jinan, Shandong, +86 250001, China

Location

Shandong Provincial Hospital affliated to Shandong University

Jinan, Shandong, +86053168773172, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Xin Ye, M.D.

    Shandong Provincial Hospital affliated to Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Ye, M.D

CONTACT

+8615168887755yexintaian2014@163.com

gang Z Wei, M.D.

CONTACT

+8618615287195weizhigang321321@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shandong Provincial Hospital affliated to Shandong University

Study Record Dates

First Submitted

August 20, 2016

First Posted

September 12, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)