Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-04-21 @ 3:01 PM
Study NCT ID:
NCT02740894
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival and neurologic outcome of 60 participants receiving targeted therapy for nonsmall cell lung cancer with spinal metastaasis. Neurological outcome by Frankel grading and ambulation status.', 'timeFrame': 'postoperation to mortality, up to 2 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Is Targeted Therapy Increasing Survival Inoperable Nonsmall Cell Lung Cancer With Spinal Metastasis ?']}, 'descriptionModule': {'briefSummary': 'Not significantly increased survival in T/T'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NSCLC with spinal metastasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NSCLC with spinal metastasis\n\nExclusion Criteria:\n\n* brain metastasis and expected survival \\< 3 months'}, 'identificationModule': {'nctId': 'NCT02740894', 'briefTitle': 'Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Can Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis of the Thoracic and Lumbar Spine?- A Retrospective Comparison With Platinum-based Chemotherapy', 'orgStudyIdInfo': {'id': '2016-02-006CC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'targeted therapy', 'description': 'according to national healthy policy, targeted therapy is the optional therapy', 'interventionNames': ['Drug: Gefitinib']}, {'label': 'traditional chemotherapy', 'description': 'according to national healthy policy, chemotherapy is the first line treatment.', 'interventionNames': ['Drug: Gefitinib']}], 'interventions': [{'name': 'Gefitinib', 'type': 'DRUG', 'otherNames': ['Targeted therapy'], 'armGroupLabels': ['targeted therapy', 'traditional chemotherapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ST Wang, Chief of spinal surgery. Taipei Veterans General Hospital, Taiwan', 'investigatorFullName': 'vghtpe user', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}