Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 9:36 AM
Study NCT ID:
NCT01301560
Status:
UNKNOWN
Last Update Posted:
2011-02-23
First Post:
2011-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
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'}, {'id': 'D019370', 'term': 'Observation'}], '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'}, {'id': 'D008722', 'term': 'Methods'}]}}, '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': 'RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2011-02-22', 'studyFirstSubmitDate': '2011-02-21', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '1 year after the enrollment of the last patient'}], 'secondaryOutcomes': [{'measure': 'Time to CNS progression', 'timeFrame': '1 year after the enrollment of the last patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asymptomatic brain metastasis', 'NSCLC', 'GKS'], 'conditions': ['Nonsmall Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '25538174', 'type': 'DERIVED', 'citation': 'Lim SH, Lee JY, Lee MY, Kim HS, Lee J, Sun JM, Ahn JS, Um SW, Kim H, Kim BS, Kim ST, Na DL, Sun JY, Jung SH, Park K, Kwon OJ, Lee JI, Ahn MJ. A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer. Ann Oncol. 2015 Apr;26(4):762-768. doi: 10.1093/annonc/mdu584. Epub 2014 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (NSCLC).\n\nTherefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed non-small cell lung cancer with synchronous brain metastases\n2. One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:\n\n * Well circumscribed tumor(s) with brain edema Grade 0-1\n * Maximum diameter ≤ 3.0 cm\n3. No prior surgical treatment or RT for brain metastases\n4. No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation\n5. Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0)\n6. Age, 18 and over\n7. ECOG performance status 0-1\n8. Written informed consent\n\nExclusion Criteria:\n\n1. severe co-morbid illness and/or active infections\n2. pregnant or lactating women\n3. RTOG neurologic function status of 1\\~4\n4. Uncontrollable extracranial metastases'}, 'identificationModule': {'nctId': 'NCT01301560', 'briefTitle': 'Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis', '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': '2008-05-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiosurgery arm', 'description': 'Radiosurgery before palliative chemotherapy', 'interventionNames': ['Radiation: Radiosurgery']}, {'type': 'NO_INTERVENTION', 'label': 'Observation arm', 'description': 'No radiotherapy or local treatment until specific symptoms or sign developed', 'interventionNames': ['Radiation: Observation']}], 'interventions': [{'name': 'Radiosurgery', 'type': 'RADIATION', 'description': 'Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC', 'armGroupLabels': ['Radiosurgery arm']}, {'name': 'Observation', 'type': 'RADIATION', 'description': 'No local treatment', 'armGroupLabels': ['Observation arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myung-Ju Ahn, Pf', 'role': 'CONTACT', 'email': 'silkahn@skku.edu', 'phone': '822-3410-3459'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Myung-Ju Ahn, Pf', 'role': 'CONTACT', 'email': 'silkahn@skku.edu', 'phone': '82-2-3410-3459'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Myung-Ju Ahn / Professor', 'oldOrganization': 'Samsung Medical Center'}}}}