Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Disease-free survival [From the date of randomization until the date of first documented progression，assessed up to 60 months]
Secondary Outcome Measures
- Overall survival [From the date of randomization until the date of death from any cause，assessed up to 60 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
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Patients with single nodule.
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Before IIB period according to the eighth edition of the TNM staging period.
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No mediastinal lymph node metastasis.
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No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
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Eastern Cooperative Oncology Group performance status of 0 to 1
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Sufficient organ functions
Exclusion Criteria:
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Active bacterial or fungous infection.
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Simultaneous or metachronous (within the past 5 years) double cancers.
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Patients with contraindications to radiofrequency ablation and inability to complete treatment;
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Women during pregnancy or breast-feeding.
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Uncontrollable diabetes mellitus.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai 10th People's Hospital | Shanghai | Shanghai | China | +86200072 |
Sponsors and Collaborators
- Shanghai 10th People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Shanghai