Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 4:55 PM
Study NCT ID:
NCT03840408
Status:
UNKNOWN
Last Update Posted:
2019-02-20
First Post:
2019-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1753}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-12', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'From the date of randomization until the date of first documented progression，assessed up to 60 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From the date of randomization until the date of death from any cause，assessed up to 60 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.\n* Patients with single nodule.\n* Before IIB period according to the eighth edition of the TNM staging period.\n* No mediastinal lymph node metastasis.\n* No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.\n* Eastern Cooperative Oncology Group performance status of 0 to 1\n* Sufficient organ functions\n\nExclusion Criteria:\n\n* Active bacterial or fungous infection.\n* Simultaneous or metachronous (within the past 5 years) double cancers.\n* Patients with contraindications to radiofrequency ablation and inability to complete treatment;\n* Women during pregnancy or breast-feeding.\n* Uncontrollable diabetes mellitus.\n* 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'}, 'identificationModule': {'nctId': 'NCT03840408', 'briefTitle': 'Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'Shanghai'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mitochondrial therapy with radiofrequency ablation', 'interventionNames': ['Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation', 'type': 'OTHER', 'description': 'Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites', 'armGroupLabels': ['Mitochondrial therapy with radiofrequency ablation']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Patients will be treated with surgery', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+86200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Li, M.D.', 'role': 'CONTACT', 'email': 'mlid163@163.com', 'phone': '+8613524348108'}], 'facility': "Shanghai 10th People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'LiH Fan, M.D.', 'role': 'CONTACT', 'email': 'fanlih@aliyun.com', 'phone': '+8613661599588'}, {'name': 'Ming Li, M.D.', 'role': 'CONTACT', 'email': 'mlid163@163.com', 'phone': '+8613524348108'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate senior doctor', 'investigatorFullName': 'Ming Li', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}