Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-02-07 @ 6:10 PM
Study NCT ID:
NCT02639650
Status:
RECRUITING
Last Update Posted:
2022-06-03
First Post:
2015-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D031901', 'term': 'Gestational Trophoblastic Disease'}], 'ancestors': [{'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': 'D005047', 'term': 'Etoposide'}, {'id': 'D003609', 'term': 'Dactinomycin'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': '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'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2015-12-13', 'studyFirstSubmitQcDate': '2015-12-20', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission rate in firstline treatment', 'timeFrame': '3 years', 'description': 'We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.'}], 'secondaryOutcomes': [{'measure': 'Severity of adverse events as assessed by the WHO', 'timeFrame': '3 years', 'description': 'We calculate the adverse events during and after chemotherapy.'}, {'measure': 'Overall Survival Rate (OR)', 'timeFrame': '3 years', 'description': 'We calculate the overall survival rate of high risk GTN patients after chemotherapy.'}, {'measure': 'Ovarian functional evaluation', 'timeFrame': 'every 6 months up to 3 years', 'description': 'We may test serum level of anti-mullerian hormone (AMH) every 6 months and the time of menstrual cycle resuming after chemotherapy.'}, {'measure': 'The pregnancy rate', 'timeFrame': '3 years', 'description': 'To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail'}]}, 'conditionsModule': {'keywords': ['gestational trophoblastic tumor', 'paclitaxel', 'cisplatin', 'carboplatin', 'chemotherapy'], 'conditions': ['Gestational Trophoblastic Neoplasms']}, 'descriptionModule': {'briefSummary': 'This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.', 'detailedDescription': 'Gestational trophoblastic tumor (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which occur in women of reproductive age. The survival rate of patients with score of 7 or more points, or WHO Ⅳ period for high-risk patients was of 60% to 80%. However, due to severe toxic reactions, long treatment time, loss of optimal reproductive age and increased costs, and treatment failure caused by chemotherapy resistance, high-risk GTN is still one of the tumors seriously affecting the life health and quality of life of young women.\n\nFirst-line chemotherapy recommended by FIGO is regimen of EMA - CO with corresponding side effects and adverse factors in the following aspects as relatively higer incidence of myelosupression, VP - 16 being associated with a second tumor, especially leukemia, and a definite effect of cyclophosphamide on the failure ovarian function Taxol (Taxol) is the most widely used and most effective broad-spectrum anti-tumor drug in gynecological malignant tumors at present, and T (paclitaxel) +P (platinum drugs) scheme is the first-line chemotherapy scheme in ovarian cancer patients at present. According to references, TP also has effects on resistant and refactory high risk GTN patients.\n\nGiven relatively simple operation way of TP chemotherapy, and the effect of chemotherapy in recurrence and high-risk refractory GTN performance,this prospective multicenter randomized controlled clinical research was to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor compared with EMA-CO.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for high-risk gestational trophoblastic neoplasia (GTN) and stage Ⅳ cases\n* World Health Organization(WHO) risk score ≥7, and less than 13\n* Age≤60 years; female, Chinese women\n* Initial treatment is chemotherapy\n* Performance status: Karnofsky score≥60\n* Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal,blood urea nitrogen, Cr≤ normal\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with unconfirmed diagnosis of GTN\n* Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)\n* WHO risk score less than 7\n* With severe or uncontrolled internal disease, unable to receive chemotherapy\n* Concurrently participating in other clinical trials\n* Unable or unwilling to sign informed consents\n* Unable or unwilling to abide by protocol'}, 'identificationModule': {'nctId': 'NCT02639650', 'briefTitle': 'Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor', 'organization': {'class': 'OTHER', 'fullName': "Women's Hospital School Of Medicine Zhejiang University"}, 'officialTitle': 'A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor', 'orgStudyIdInfo': {'id': 'ZJHGTN1211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle', 'interventionNames': ['Drug: Etoposide', 'Drug: actinomycin D', 'Drug: methotrexate', 'Drug: vincristine', 'Drug: cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'paclitaxel + cisplatin or carboplatin，two weeks a cycle', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Cisplatin', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['VP-16'], 'description': 'etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle', 'armGroupLabels': ['control group']}, {'name': 'actinomycin D', 'type': 'DRUG', 'otherNames': ['ACTD', 'Sanamycin'], 'description': 'actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle', 'armGroupLabels': ['control group']}, {'name': 'methotrexate', 'type': 'DRUG', 'otherNames': ['MTX'], 'description': 'methotrexate 100mg/m2, 200mg/m2, ivgtt, tetrahydrofolic acid （FA) 15mg q12h\\*4(24h after methotrexate injection),started at the first day of cycle, two weeks a cycle', 'armGroupLabels': ['control group']}, {'name': 'vincristine', 'type': 'DRUG', 'otherNames': ['VCR'], 'description': 'vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle', 'armGroupLabels': ['control group']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['CTX'], 'description': 'cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle', 'armGroupLabels': ['control group']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle', 'armGroupLabels': ['study group']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['DDP'], 'description': 'cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle', 'armGroupLabels': ['study group']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['CBP'], 'description': 'carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiguo Lv, Doctor', 'role': 'CONTACT'}], 'facility': 'Weiguo Lv', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Lu Weiguo, Doctor', 'role': 'CONTACT', 'email': 'lbwg@zju.edu.cn', 'phone': '86-13588819218'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weiguo Lv', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shandong University', 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Zhongshan Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice-President', 'investigatorFullName': 'Weiguo Lv', 'investigatorAffiliation': "Women's Hospital School Of Medicine Zhejiang University"}}}}