Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT01926769
Status:
TERMINATED
Last Update Posted:
2018-05-15
First Post:
2013-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Study to Determine the Safety and Efficacy of Second-line Treatment With Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the Second Line Threatment of Advanced Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Slow accrual rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2013-08-19', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Control Rate', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': 'one year'}, {'measure': 'Overall Survival', 'timeFrame': 'one year'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'one year'}, {'measure': 'Progression Free Survival', 'timeFrame': 'one year'}]}, 'conditionsModule': {'keywords': ['Colorectal cancer', 'Metformin', 'FOLFOX6', 'FOFIRI', '5FU', 'irinotecan', 'oxaliplatin'], 'conditions': ['Previously Treated Advanced Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of second-line treatment with Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the second line treatment of advanced colorectal cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18\n* histologically confirmted advanced colorectal cancer\n* ECOG PS 0-2\n* expected life span more than 3months\n* normal bone marrow, liver, renal function\n\nExclusion Criteria:\n\n* 5-FU, oxaliplatin, irinotecan or Metformin Allergic history\n* Lactic acidosis, metabolic acidosis\n* active infection or severe neuropathy'}, 'identificationModule': {'nctId': 'NCT01926769', 'briefTitle': 'A Phase II Study to Determine the Safety and Efficacy of Second-line Treatment With Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the Second Line Threatment of Advanced Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'orgStudyIdInfo': {'id': '2012-GIRBA-2675'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FOLFOX6+Metformin/FOFIRI+Metformin', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'armGroupLabels': ['FOLFOX6+Metformin/FOFIRI+Metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hee Kyung Ahn', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}