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

Not Applicable

• Conditions: Non Small Cell Lung Cancer
• Interventions: Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation; Procedure: Surgery

• Registration Number: NCT03840408
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1753

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitochondrial therapy with radiofrequency ablation	Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation	-
Surgery	Surgery	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival	From the date of randomization until the date of first documented progression，assessed up to 60 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	From the date of randomization until the date of death from any cause，assessed up to 60 months

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China