Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer

February 18, 2019 updated by: Ming Li, Shanghai 10th People's Hospital

Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer

Lung cancer is 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. Mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1753

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, +86200072
        • Recruiting
        • Shanghai 10th People's Hospital

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
  • Patients with single nodule.
  • Before IIB period according to the eighth edition of the TNM staging period.
  • No mediastinal lymph node metastasis.
  • No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
  • Eastern Cooperative Oncology Group performance status of 0 to 1
  • Sufficient organ functions

Exclusion Criteria:

  • Active bacterial or fungous infection.
  • Simultaneous or metachronous (within the past 5 years) double cancers.
  • Patients with contraindications to radiofrequency ablation and inability to complete treatment;
  • Women during pregnancy or breast-feeding.
  • Uncontrollable diabetes mellitus.
  • Patients with severe heart, lung, kidney disease or other systemic diseases who have been judged to have a severe impact on survival or who are pre-assessed to be unable to tolerate thoracoscopic surgery

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mitochondrial therapy with radiofrequency ablation
Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation
Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites
Active Comparator: Surgery
Procedure: Surgery
Patients will be treated with surgery

What is the study measuring?

Primary 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 60 months
From the date of randomization until the date of first documented progression，assessed up to 60 months

Secondary 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 60 months
From the date of randomization until the date of death from any cause，assessed up to 60 months

Collaborators and Investigators

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

Sponsor

Shanghai 10th People's Hospital

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 (Actual)

January 31, 2019

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shanghai

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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