Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-30 @ 5:04 AM
Study NCT ID:
NCT03464968
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2018-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2018-03-01', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 months overall survival rate', 'timeFrame': '6months', 'description': 'at 6 months from intervention treatment, overall survival rate'}], 'secondaryOutcomes': [{'measure': 'response rate', 'timeFrame': '6months', 'description': 'complete response, partial response'}, {'measure': 'disease control rate', 'timeFrame': '6months', 'description': 'complete response, partial response, stable disease'}, {'measure': 'progression free survival', 'timeFrame': '6months', 'description': 'from treatment start to progression or any cause of death'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0', 'timeFrame': '6months', 'description': 'percentage of all patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['second line', 'FOLFOX', 'FOLFIRI'], 'conditions': ['Biliary Cancer Metastatic']}, 'referencesModule': {'references': [{'pmid': '34303267', 'type': 'DERIVED', 'citation': 'Choi IS, Kim KH, Lee JH, Suh KJ, Kim JW, Park JH, Kim YJ, Kim JS, Kim JH, Kim JW. A randomised phase II study of oxaliplatin/5-FU (mFOLFOX) versus irinotecan/5-FU (mFOLFIRI) chemotherapy in locally advanced or metastatic biliary tract cancer refractory to first-line gemcitabine/cisplatin chemotherapy. Eur J Cancer. 2021 Sep;154:288-295. doi: 10.1016/j.ejca.2021.06.019. Epub 2021 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.', 'detailedDescription': '1. brief enrollment criteria\n\n * histological confirmed\n * refractory to first line gemcitabine plus cisplatin\n * fit for chemotherapy\n2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks\n\n B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks\n3. randomization - stratified by tumor site and performance status'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years and older\n* pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater\n* initially inoperable or recurrent\n* ECOG 0-2\n* as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)\n* evaluable or measurable lesion\n* within 1 week, patients who meet below laboratory results (hemoglobin \\>9.0 g/dL, neutrophil \\>1000/uL, platelet\\> 75000/uL, serum creatinine \\< UNL \\* 1.5, AST/ALT \\< UNL\\*3, total bilirubin \\< UNL\\*1.5 (available for biliary drainage)\n* patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage\n\nExclusion Criteria:\n\n* other cancer history\n* pregnant or lactating\n* uncontrolled medical condition such as infection or cardiovascular disease\n* hypersensitivity to experimental drugs\n* uncontrolled CNS metastasis, psychologic problem'}, 'identificationModule': {'nctId': 'NCT03464968', 'briefTitle': 'mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin', 'orgStudyIdInfo': {'id': 'biliary second line'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mFOLFOX', 'description': 'D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks', 'interventionNames': ['Drug: Oxaliplatin,5FU, leucovorin']}, {'type': 'EXPERIMENTAL', 'label': 'mFOLFIRI', 'description': 'D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks', 'interventionNames': ['Drug: irinotecan,5FU, leucovorin']}], 'interventions': [{'name': 'Oxaliplatin,5FU, leucovorin', 'type': 'DRUG', 'description': 'mFOLFOX', 'armGroupLabels': ['mFOLFOX']}, {'name': 'irinotecan,5FU, leucovorin', 'type': 'DRUG', 'description': 'mFOLFIRI', 'armGroupLabels': ['mFOLFIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Jin Won Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}