Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-29 @ 1:23 PM
Study NCT ID:
NCT04337632
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053518', 'term': 'CP protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 338}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS（Progression-Free-Survival)', 'timeFrame': 'up to 24months', 'description': 'From the date of randomization to the time of tumor progression'}], 'secondaryOutcomes': [{'measure': 'OS(Overall survival)', 'timeFrame': 'up to 36months', 'description': 'Time from random day to death (month)'}, {'measure': 'ORR( Objective response rate)', 'timeFrame': 'up to 12 months', 'description': 'the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective, randomized studies.Evaluation of the sensitivity to different chemotherapy regimens in platinum-partial sensitive recurrent ovarian cancer based on 11 gene tests of homologous recombination pathway.', 'detailedDescription': 'Patients meeting the following inclusion criteria were randomly divided into two groups in a 1:1 ratio: paclitaxel/platinum chemotherapy group (TP) and Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy group (PP) (the specific chemotherapy regimens are as follows.Chemotherapy to tumor progression or adverse reactions can not be tolerated, effective chemotherapy patients with a maximum of 6 cycles of chemotherapy.The primary endpoint was progression-free survival (PFS), and the secondary endpoints were safety and overall survival.Also USES the next-generation sequencing (NGS) method to detect patients with recurrence after tumor tissues (including chest, ascites, homologous recombination pathway in the tumor tissue and peripheral blood ctDNA 11 genetic mutations, rearrangement, and so on and so forth, whether patients with analysing the homologous recombination pathways for paclitaxel/platinum chemotherapy or Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy has different sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age: 18-75 years old\n2. PS score: ECOG 0 \\~ 2\n3. histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum;\n4. the time interval between this recurrence and the last chemotherapy was 6-12 months;\n5. evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy;\n6. expected survival over 3 months;\n7. sign the informed consent.\n\nExclusion Criteria:\n\n1. brain metastasis or the presence of symptoms caused by brain metastasis;\n2. serious complications;\n3. acute inflammatory reaction;\n4. other tumors;\n5. a history of allergy to paclitaxel or polyropyridone liposomes;'}, 'identificationModule': {'nctId': 'NCT04337632', 'briefTitle': 'Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Cancer Hospital'}, 'officialTitle': 'Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer Based on 11 Gene Tests of Homologous Recombination Pathway', 'orgStudyIdInfo': {'id': '2016YFC1303703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PP', 'description': 'Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks.', 'interventionNames': ['Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TP', 'description': 'paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.', 'interventionNames': ['Drug: paclitaxel +carboplatin']}], 'interventions': [{'name': 'Doxorubicin Hydrochloride Liposome Injection+carboplatin', 'type': 'DRUG', 'otherNames': ['PP'], 'description': 'Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.', 'armGroupLabels': ['PP']}, {'name': 'paclitaxel +carboplatin', 'type': 'DRUG', 'otherNames': ['TP'], 'description': 'paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.', 'armGroupLabels': ['TP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Wang, MD.', 'role': 'CONTACT', 'email': 'wangjing@hnca.org.cn', 'phone': '(86-0731)88651849'}, {'name': 'Jing Su, MD.', 'role': 'CONTACT', 'email': 'sujing@hnca.org.cn', 'phone': '(86-0731)89762815'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Jing Wang, MD.', 'role': 'CONTACT', 'email': 'wangjing@hnca.org.cn', 'phone': '（86-0731）88651849'}, {'name': 'Jing Su, MD.', 'role': 'CONTACT', 'email': 'sujing@hnca.org.cn', 'phone': '（86-0731）89762815'}], 'overallOfficials': [{'name': 'Jing Wang, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hunan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'JingWang', 'investigatorAffiliation': 'Hunan Cancer Hospital'}}}}