Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-03 @ 7:25 AM
Study NCT ID:
NCT01758666
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2012-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'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': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2012-08-30', 'studyFirstSubmitQcDate': '2012-12-31', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood concentration of MTX', 'timeFrame': 'up to 3 years'}], 'secondaryOutcomes': [{'measure': 'other adverse reaction', 'timeFrame': 'up to 3 years'}]}, 'conditionsModule': {'conditions': ['Osteosarcoma']}, 'descriptionModule': {'briefSummary': 'At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX, the survival rate can reach about 60%, so the HD-MTX is the most important component in patients of osteosarcoma.\n\nStudies have shown that, MTX efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give CF is the critical point.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Proved by pathology in 60 cases of osteosarcoma patients\n2. PS ≤ 2, survival period is more than 6 months\n3. Normal function of liver and kidney\n4. No chemotherapy contraindication, patients treat with high dose methotrexate\n5. Get signed written informed consent form\n6. Have a good compliance with take blood and follow-up\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01758666', 'briefTitle': 'A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'orgStudyIdInfo': {'id': 'CIH-WAC-201205001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methotrexate and Calcium folinate', 'interventionNames': ['Drug: Methotrexate,Calcium folinate']}], 'interventions': [{'name': 'Methotrexate,Calcium folinate', 'type': 'DRUG', 'armGroupLabels': ['Methotrexate and Calcium folinate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chen Wang', 'role': 'STUDY_CHAIR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}