Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT06535334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-02
First Post:
2024-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RFS', 'timeFrame': 'the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up', 'description': 'Recurrence free survival'}, {'measure': 'OS', 'timeFrame': 'the time interval from the date of surgery or the start of chemotherapy to the date of death from any cause or last follow-up', 'description': 'Overall Survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'woman with recurrent ovarian cancer who was treated with chemotherapy (either intravenous or intraperitoneal)', 'genderDescription': 'women with ovarian cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women who had recurrent ovarian cancer and was treated with either intravenous or intraperitoneal platinum based chemotherapy\n\nExclusion Criteria:\n\n* women who did not complete the designated treatment course (exception to those who had to quit due to progressive disease or death of any cause)'}, 'identificationModule': {'nctId': 'NCT06535334', 'briefTitle': 'Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': '113130-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intravenous chemotherapy', 'description': 'triweekly chemotherapy with carboplatin AUC=5\\~6 + liposomal-doxorubicin 30\\~40mg/m2 or paclitaxel 175mg/m2 0r docetaxel 60\\~75mg/m2', 'interventionNames': ['Drug: Chemotherapy']}, {'label': 'intraperitoneal chemotherapy', 'description': 'Day 1 IV Paclitaxel 135 mg/m2 + IP Cisplatin 75-100 mg/m2 or IP carboplatin (AUC = 6) Day 8 IP Paclitaxel 60 mg/m2 Every 21 days \\* 6 cycles\n\nOR\n\nDay 1 IP Carboplatin AUC=5 or IP Cisplatin 50-75mg/m2 Day 2 IV Liposomal doxorubicin 15 mg/m2 + IP Liposomal doxorubicin 15 mg/m2 Every 28 days \\* 6 cycles', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Intravenous chemotherapy versus intraperitoneal chemotherapy in recurrent ovarian cancer', 'armGroupLabels': ['intraperitoneal chemotherapy', 'intravenous chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22050', 'city': 'Banqiao District', 'state': 'New Taipei', 'country': 'Taiwan', 'facility': 'Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sheng-Mou Hsiao', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}