Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-25 @ 12:35 PM
Study NCT ID:
NCT01125995
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2010-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '36 months'}, {'measure': 'objective response rate', 'timeFrame': '6 months'}, {'measure': 'Progression-free survival', 'timeFrame': '36 months'}, {'measure': 'toxicity by NCI common toxicity version 2.0', 'timeFrame': '36 months'}]}, 'conditionsModule': {'keywords': ['limited disease'], 'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed small-cell lung cancer\n* limited disease status\n* with evaluable disease\n* 18 years or older\n* ECOG performance status 0,1,2\n* expected survival time should be 12 weeks or longer\n* Adequate organ function as evidenced by the following; Absolute neutrophil count \\> 1.5 x 109/L; platelets \\> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \\< 5 UNL; creatinine clearance ≥ 50mL/min\n* Written informed consent form\n\nExclusion Criteria:\n\n1. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia\n2. Patients with active infection requiring antibiotics\n3. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)\n4. Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer\n5. previous history of chemotherapy or radiotherapy'}, 'identificationModule': {'nctId': 'NCT01125995', 'briefTitle': 'Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer', 'orgStudyIdInfo': {'id': '2003-02-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'late CCRT', 'description': 'radiotherapy start on day one of the third cycle of chemotherapy', 'interventionNames': ['Radiation: late CCRT']}, {'type': 'EXPERIMENTAL', 'label': 'Early CCRT', 'description': 'Radiotherapy start on day 1 of 1st cycle of chemotherapy', 'interventionNames': ['Radiation: early CCRT']}], 'interventions': [{'name': 'early CCRT', 'type': 'RADIATION', 'description': '1. patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 \\& Cisplatin 70mg/m2 D1.\n2. radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy).', 'armGroupLabels': ['Early CCRT']}, {'name': 'late CCRT', 'type': 'RADIATION', 'description': '1. patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 \\& Cisplatin 70mg/m2 D1.\n2. radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy).', 'armGroupLabels': ['late CCRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Keunchil Park', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medican Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Keunchil Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Keunchil Park', 'investigatorAffiliation': 'Samsung Medical Center'}}}}