Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-06 @ 7:37 PM
Study NCT ID:
NCT01806259
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2013-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ketorolac in Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
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True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ketorolac 30 mg', 'description': 'Active drug to be compared with placebo\n\nKetorolac 30 mg IV', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'NaCl 0.9% 3mL', 'description': 'Placebo looking like the Active drug', 'otherNumAtRisk': 107, 'otherNumAffected': 0, 'seriousNumAtRisk': 107, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'Any type (not bleeding related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma requiring surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recurrence-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac 30 mg', 'description': 'Active drug to be compared with placebo\n\nKetorolac 30 mg IV'}, {'id': 'OG001', 'title': 'NaCl 0.9% 3mL', 'description': 'Ketorolac 30 mg IV'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': '2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac 30 mg', 'description': 'Active drug to be compared with placebo\n\nKetorolac 30 mg IV'}, {'id': 'OG001', 'title': 'NaCl 0.9% 3mL', 'description': 'Placebo looking like the Active drug'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': '2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of death from any cause assessed up to 5 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketorolac 30 mg', 'description': 'Active drug to be compared with placebo\n\nKetorolac 30 mg IV'}, {'id': 'FG001', 'title': 'NaCl 0.9% 3mL', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketorolac 30 mg', 'description': 'Active drug to be compared with placebo\n\nKetorolac 30 mg IV'}, {'id': 'BG001', 'title': 'NaCl 0.9% 3mL', 'description': 'Ketorolac 30 mg IV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.1', 'spread': '14', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '55.7', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2013-02-20', 'resultsFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2013-03-05', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-06', 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': '2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of death from any cause assessed up to 5 years)'}], 'primaryOutcomes': [{'measure': 'Recurrence-free Survival', 'timeFrame': '5 years', 'description': '2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Curative Breast Cancer Surgery', 'Inflammatory Positive/Negative Status', 'Pre Surgical Incision Administration']}, 'referencesModule': {'references': [{'pmid': '20435950', 'type': 'BACKGROUND', 'citation': 'Forget P, Vandenhende J, Berliere M, Machiels JP, Nussbaum B, Legrand C, De Kock M. Do intraoperative analgesics influence breast cancer recurrence after mastectomy? A retrospective analysis. Anesth Analg. 2010 Jun 1;110(6):1630-5. doi: 10.1213/ANE.0b013e3181d2ad07. Epub 2010 Apr 30.'}, {'pmid': '31800611', 'type': 'DERIVED', 'citation': 'Forget P, Bouche G, Duhoux FP, Coulie PG, Decloedt J, Dekleermaker A, Guillaume JE, Ledent M, Machiels JP, Mustin V, Swinnen W, van Maanen A, Vander Essen L, Verougstraete JC, De Kock M, Berliere M. Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial. PLoS One. 2019 Dec 4;14(12):e0225748. doi: 10.1371/journal.pone.0225748. eCollection 2019.'}, {'pmid': '23937996', 'type': 'DERIVED', 'citation': 'Forget P, Berliere M, van Maanen A, Duhoux FP, Machiels JP, Coulie PG, Bouche G, De Kock M; Ketorolac in Breast Cancer trial (KBCtrial) group. Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial. Med Hypotheses. 2013 Oct;81(4):707-12. doi: 10.1016/j.mehy.2013.07.033. Epub 2013 Aug 9.'}], 'seeAlsoLinks': [{'url': 'http://www.anesthesia-analgesia.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWritten informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio \\>4 and/or "triple negative" histological status and/or Positive lymph nodes\n\nExclusion Criteria:\n\nPrevious cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )'}, 'identificationModule': {'nctId': 'NCT01806259', 'acronym': 'KBCt', 'briefTitle': 'Ketorolac in Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': 'KBCtrial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ketorolac 30 mg', 'description': 'Active drug to be compared with placebo', 'interventionNames': ['Drug: Ketorolac 30 mg IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl 0.9% 3mL', 'description': 'Placebo looking like the Active drug', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Ketorolac 30 mg IV', 'type': 'DRUG', 'otherNames': ['ketorolac tromethamine'], 'description': 'Active drug', 'armGroupLabels': ['ketorolac 30 mg']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['NaCl 0.9%'], 'description': 'Placebo looking like the Active drug', 'armGroupLabels': ['NaCl 0.9% 3mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Patrice Forget, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anticancer Fund, Belgium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Docteur', 'investigatorFullName': 'Patrice Forget', 'investigatorAffiliation': 'Université Catholique de Louvain'}}}}