Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-29 @ 8:04 AM
Study NCT ID:
NCT00955695
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2009-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D002282', 'term': 'Adenocarcinoma, Bronchiolo-Alveolar'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 242}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2009-08-07', 'studyFirstSubmitQcDate': '2009-08-07', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to symptomatic brain metastases'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival'}, {'measure': 'Overall survival'}, {'measure': 'Safety and tolerability of prophylactic cranial radiotherapy'}, {'measure': 'Psycho-neurological effects of prophylactic cranial radiotherapy'}, {'measure': 'Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically'}]}, 'conditionsModule': {'keywords': ['adenocarcinoma of the lung', 'adenosquamous cell lung cancer', 'bronchoalveolar cell lung cancer', 'large cell lung cancer', 'squamous cell lung cancer', 'stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.\n\nPURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.\n\nSecondary\n\n* Determine the progression-free survival in patients treated with this regimen.\n* Determine the overall survival in patients treated with this regimen.\n* Determine the safety and tolerability of this regimen in these patients.\n* Determine the psycho-neurological effects of this regimen in these patients.\n* Determine the quality of life of patients treated with this regimen.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.\n\n* Group 1: Patients undergo prophylactic brain radiotherapy.\n* Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.\n\nAfter completion of study therapy, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed non-small cell lung cancer\n\n * Stage IIIB or IV disease\n * Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy\n* At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride\n\n * Stable disease allowed provided 1 of the following criteria is met:\n\n * EGFR mutation (exon 19 or 21)\n * Having ≥ 2 of the following 3 factors:\n\n * Female\n * Never smoked\n * Histologically confirmed adenocarcinoma of the lung\n* No evidence of brain metastases by CT scan or MRI within the past 4 weeks\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* ANC ≥ 1,500/mm\\^3\n* Platelet count ≥ 150,000/mm\\^3\n* Bilirubin \\< 1.5 mg/dL\n* Serum creatinine \\< 1.5 times upper limit of normal\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Received 1 or 2 prior systemic chemotherapy regimens'}, 'identificationModule': {'nctId': 'NCT00955695', 'briefTitle': 'Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Nonprogressive on Gefitinib or Erlotinib', 'orgStudyIdInfo': {'id': 'KROG-4-2008-0276'}, 'secondaryIdInfos': [{'id': 'CDR0000639096', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'erlotinib hydrochloride', 'type': 'DRUG'}, {'name': 'gefitinib', 'type': 'DRUG'}, {'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}, {'name': 'whole-brain radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chang Geol Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}}}}