Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
1 other identifier
interventional
1,753
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2019
CompletedFirst Submitted
Initial submission to the registry
February 12, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedFebruary 20, 2019
February 1, 2019
5 years
February 12, 2019
February 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival
From the date of randomization until the date of first documented progression，assessed up to 60 months
Secondary Outcomes (1)
Overall survival
From the date of randomization until the date of death from any cause，assessed up to 60 months
Study Arms (2)
Mitochondrial therapy with radiofrequency ablation
EXPERIMENTALSurgery
ACTIVE COMPARATORInterventions
Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, +86200072, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate senior doctor
Study Record Dates
First Submitted
February 12, 2019
First Posted
February 15, 2019
Study Start
January 31, 2019
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
February 20, 2019
Record last verified: 2019-02