Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-15 @ 8:29 AM
Study NCT ID:
NCT03916367
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2019-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT-guided Radioactive I-125 Seeds Implantation for Early Stage 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-19', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control time', 'timeFrame': 'Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.', 'description': 'The time from the date of seeds implantation to the date of recurrence of the implanted tumor or the date of last observation.'}, {'measure': 'Overall survival time', 'timeFrame': 'Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.', 'description': 'The time from the date of seeds implantation to the date of death from any cause or the date of last observation.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Outcomes were followed up every 3 months after seeds implantation. The last follow-up timepoint is February 2019.', 'description': 'The adverse events were evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event was measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radioactive iodine-125 seeds implantation', 'non-small cell lung cancer', 'early stage'], 'conditions': ['Early Stage Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study observes the efficacy and side effects of CT-guided radioactive iodine-125 seed brachytherapy in inoperable early stage non-small cell lung cancer retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.', 'detailedDescription': 'Radioactive Iodine-125 seed brachytherapy is a conventional treatment in Peking University Third Hospital. Radioactive Iodine-125 seed brachytherapy is the implantation of Iodine-125 seed into tumors.The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. This study collects the data of patients with early stage (stage I-II, N0) non-small cell lung cancer who underwent CT-guided radioactive Iodine-125 seed implantation from 2010 to 2018. The investigators evaluate the dose that covers 90% target volume(D90) and other parameters after the implantation. The efficacy and adverse effects were observed. Local control(LC) time and overall survival(OS) time are evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with early stage non-small cell lung cancer who were treated with CT-guided radioactive iodine-125 seeds implantation during December 2010 to December 2018 were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histological proven non-small cell lung cancer\n* UICC (Union for International Cancer Control) stage was T1-3N0M0 (stage Ia-IIb)\n* inoperable and CT-guided radioactive iodine-125 seeds brachytherapy was used as the initial treatment without external beam radiotherapy\n\nExclusion Criteria:\n\n* actual dose of covers 90% target volume (D90) less than 100 Gy in postoperative validation\n* case information and/or follow-up information was unavailable'}, 'identificationModule': {'nctId': 'NCT03916367', 'briefTitle': 'CT-guided Radioactive I-125 Seeds Implantation for Early Stage Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Clinical Outcome of CT-guided Radioactive Iodine-125 Seeds Implantation for Inoperable Early Stage Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CNRBG-81532-ESNSCLC-RISI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early Stage Lung Cancer', 'description': 'The patients with early stage non-small cell lung cancer who were treated with CT-guided radioactive iodine-125 seeds implantation during December 2010 to December 2018.', 'interventionNames': ['Radiation: CT-guided Radioactive I-125 Seeds Implantation']}], 'interventions': [{'name': 'CT-guided Radioactive I-125 Seeds Implantation', 'type': 'RADIATION', 'description': 'The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring.', 'armGroupLabels': ['Early Stage Lung Cancer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Junjie Wang, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Data will be available within 6 months of the study completion.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available.', 'accessCriteria': 'Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}