Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-28 @ 9:38 PM
Study NCT ID:
NCT01130766
Status:
UNKNOWN
Last Update Posted:
2010-05-26
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC)
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': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-05-25', 'lastUpdatePostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'time to CNS progression', 'timeFrame': '36 months'}, {'measure': 'time to symptomatic brain metastasis', 'timeFrame': '36 months'}, {'measure': 'quality of life', 'timeFrame': '36 months'}, {'measure': 'cause of death (neurologic vs. others)', 'timeFrame': '36 months'}, {'measure': 'neurocognitive function', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-small Cell Lung Cancer', 'Asymptomatic brain metastasis', 'Stereotactic radiosurgery (SRS)'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The prognosis of NSCLC patients with asymptomatic brain metastasis, who are not treated with SRS or WBRT has not been fully investigated yet. This randomized phase III trial is conducted to determine the exact role of SRS in NSCLC patients with asymptomatic oligo brain metastases whether early treatment with SRS would improve survival even in patients with asymptomatic brain metastasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed non-small cell lung cancer with synchronous brain metastases (diagnosis of brain lesion before or within 2 months from diagnosis of the primary site tumor)\n\n * One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:\n\n 1. Well circumscribed tumor(s) with brain edema Grade 0-1\n 2. Maximum diameter ≤ 3.0 cm\n\n * No prior complete resection of all known brain metastases or RT ④ No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation\n\n * Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0) ⑥ Age, 18 and over ⑦ ECOG performance status 0-1 ⑧ Written informed consent\n\n Exclusion Criteria:\n* severe co-morbid illness and/or active infections ② pregnant or lactating women\n\n * RTOG neurologic function status of 1\\~4 ④ Uncontrollable extracranial metastases'}, 'identificationModule': {'nctId': 'NCT01130766', 'briefTitle': 'Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': '2009-01-059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stereotactic radiosurgery (SRS)', 'interventionNames': ['Procedure: stereotactic radiosurgery (SRS)']}, {'type': 'NO_INTERVENTION', 'label': 'observation'}], 'interventions': [{'name': 'stereotactic radiosurgery (SRS)', 'type': 'PROCEDURE', 'description': 'Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)', 'armGroupLabels': ['stereotactic radiosurgery (SRS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Myungju Ahn, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Myungju Ahn Ph.D., M.D.', 'oldOrganization': 'Samsung Medical Center'}}}}