Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-05 @ 11:31 PM
Study NCT ID:
NCT00003702
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Japan', 'South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006828', 'term': 'Hydatidiform Mole'}], 'ancestors': [{'id': 'D031901', 'term': 'Gestational Trophoblastic Disease'}, {'id': 'D014328', 'term': 'Trophoblastic Neoplasms'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011252', 'term': 'Pregnancy Complications, Neoplastic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003609', 'term': 'Dactinomycin'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C015342', 'term': 'merphos'}], 'ancestors': [{'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kurasa@nrgoncology.org', 'phone': '7168455702', 'title': 'Angela M. Kuras on behalf of Virginia Filiaci', 'organization': 'NRG Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through Study completion, an average of 7 months.', 'description': 'The frequencies of any serious adverse event or other adverse events (grade 2 or higher) by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported. Adverse events were collected by Organ System Class.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Methotrexate 30 mg/m2 IM Weekly', 'description': 'Arm 1: Methotrexate 30 mg/m2 IM weekly', 'otherNumAtRisk': 107, 'otherNumAffected': 50, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks', 'description': 'Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks', 'otherNumAtRisk': 107, 'otherNumAffected': 68, 'seriousNumAtRisk': 107, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Other Hemotologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Constitutional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dermatologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Genitourinary/Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hepatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Infection/Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Neurologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Ocular/Visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Sexual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'seriousEvents': [{'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Methotrexate 30 mg/m2 IM Weekly', 'description': 'Arm 1: Methotrexate 30 mg/m2 IM weekly'}, {'id': 'OG001', 'title': 'Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks', 'description': 'Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks'}], 'classes': [{'title': 'Complete/Cure', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Non-response', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Inevaluable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.', 'description': 'Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received a random treatment allocation'}, {'type': 'PRIMARY', 'title': 'Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Methotrexate 30 mg/m2 IM Weekly', 'description': 'Arm 1: Methotrexate 30 mg/m2 IM weekly'}, {'id': 'OG001', 'title': 'Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks', 'description': 'Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.', 'description': 'Number of participants with a maximum grade of 3 or higher during the treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated patients'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Decline of hCG on Day 1 of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Participants', 'description': 'Enrolled participants that had a subsequent hCG measurement after enrollment and before treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to study entry and on Day 1 of treatment', 'description': 'Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Methotrexate 30 mg/m2 IM Weekly', 'description': 'Arm 1: Methotrexate 30 mg/m2 IM weekly'}, {'id': 'FG001', 'title': 'Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks', 'description': 'Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Ineligible cell types', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Did not meet criteria for persistence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'WHO score > 6', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Inadequate documentation of disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This trial opened to patient accrual on 6/14/1999 and closed to accrual on 2/26/2007.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Methotrexate 30 mg/m2 IM Weekly', 'description': 'Arm 1: Methotrexate 30 mg/m2 IM weekly'}, {'id': 'BG001', 'title': 'Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks', 'description': 'Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '1999-11-01', 'resultsFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-12', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay', 'timeFrame': 'Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.', 'description': 'Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.'}, {'measure': 'Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0', 'timeFrame': 'Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.', 'description': 'Number of participants with a maximum grade of 3 or higher during the treatment period.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With a Decline of hCG on Day 1 of Treatment', 'timeFrame': 'Prior to study entry and on Day 1 of treatment', 'description': 'Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start.'}]}, 'conditionsModule': {'conditions': ['Good Prognosis Metastatic Gestational Trophoblastic Tumor', 'Hydatidiform Mole', 'Non-Metastatic Gestational Trophoblastic Tumor', 'Uterine Corpus Choriocarcinoma']}, 'descriptionModule': {'briefSummary': 'Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.', 'detailedDescription': 'OBJECTIVES:\n\nI. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia.\n\nII. Compare the toxicity of these regimens in these patients. III. Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate (as determined by the likelihood that the beta human chorionic gonadotropin \\[HCG\\] titer would decline on the day treatment is initiated).\n\nOUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. All patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.\n\nPatients are followed every 4 weeks for 1 year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:\n\n * Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers\n * Greater than 20% sustained rise in beta HCG titer over two consecutive weeks\n * Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum)\n * Histologically proven nonmetastatic choriocarcinoma\n * Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm)\n* WHO score 0-6 (not including blood group or CT lung)\n* No histologically confirmed placental site pseudotumor\n* Must have undergone at least 1 uterine curettage\n* Previously untreated disease\n* Performance status - GOG 0-2\n* WBC at least 3,000/mm\\^3\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGPT and SGOT no greater than 3 times ULN\n* Alkaline phosphatase no greater than 3 times ULN\n* No significant prior abnormal hepatic function\n* Creatinine no greater than 2.0 mg/dL\n* No significant prior abnormal renal function\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for one year after study entry\n* No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer\n* No prior chemotherapy for gestational trophoblastic neoplasia\n* No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor'}, 'identificationModule': {'nctId': 'NCT00003702', 'briefTitle': 'Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia', 'orgStudyIdInfo': {'id': 'GOG-0174'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02026', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ECOG-G174'}, {'id': 'CDR0000066809'}, {'id': 'GOG-0174', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'GOG-0174', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (methotrexate)', 'description': 'Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (dactinomycin)', 'description': 'Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.', 'interventionNames': ['Biological: Dactinomycin']}], 'interventions': [{'name': 'Dactinomycin', 'type': 'BIOLOGICAL', 'otherNames': ['Actinomycin A IV', 'Actinomycin C1', 'ACTINOMYCIN D', 'Actinomycin I1', 'Actinomycin IV', 'Actinomycin X 1', 'Actinomycin-[thr-val-pro-sar-meval]', 'Cosmegen', 'DACT', 'Dactinomycine', 'Lyovac Cosmegen', 'Meractinomycin'], 'description': 'Given IV', 'armGroupLabels': ['Arm II (dactinomycin)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Abitrexate', 'Alpha-Methopterin', 'Amethopterin', 'Brimexate', 'CL 14377', 'CL-14377', 'Emtexate', 'Emthexat', 'Emthexate', 'Farmitrexat', 'Fauldexato', 'Folex', 'Folex PFS', 'Lantarel', 'Ledertrexate', 'Lumexon', 'Maxtrex', 'Medsatrexate', 'Metex', 'Methoblastin', 'Methotrexate LPF', 'Methotrexate Methylaminopterin', 'Methotrexatum', 'Metotrexato', 'Metrotex', 'Mexate', 'Mexate-AQ', 'MTX', 'Novatrex', 'Rheumatrex', 'Texate', 'Tremetex', 'Trexeron', 'Trixilem', 'WR-19039'], 'description': 'Given intramuscularly', 'armGroupLabels': ['Arm I (methotrexate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Gynecologic Oncology Group', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Raymond Osborne', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecologic Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}