Back to resultsMitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Shanghai 10th People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mitochondrial therapy with radiofrequency ablation
Surgery
Arm Description
Outcomes
Primary Outcome Measures
Disease-free survival
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT03840408
First Posted
February 12, 2019
Last Updated
February 18, 2019
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03840408
Brief Title
Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Official Title
Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1753 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mitochondrial therapy with radiofrequency ablation
Arm Type
Experimental
Arm Title
Surgery
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation
Intervention Description
Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Patients will be treated with surgery
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
From the date of randomization until the date of first documented progression，assessed up to 60 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
From the date of randomization until the date of death from any cause，assessed up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LiH Fan, M.D.
Phone
+8613661599588
Email
fanlih@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Li, M.D.
Phone
+8613524348108
Email
mlid163@163.com
Facility Information:
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
+86200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Li, M.D.
Phone
+8613524348108
Email
mlid163@163.com
12. IPD Sharing Statement
Learn more about this trial
Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
We'll reach out to this number within 24 hrs