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Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639650
Recruitment Status : Recruiting
First Posted : December 24, 2015
Last Update Posted : October 4, 2018
Sponsor:
Collaborators:
Shandong University
Huazhong University of Science and Technology
First Affiliated Hospital of Zhongshan Medical University
Information provided by (Responsible Party):
Weiguo Lv, Women's Hospital School Of Medicine Zhejiang University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Neoplasms Drug: Etoposide Drug: actinomycin D Drug: methotrexate Drug: vincristine Drug: cyclophosphamide Drug: Paclitaxel Drug: Cisplatin Drug: Carboplatin Phase 3

Detailed Description:

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.

First-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.

Given 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: control group
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
 Drug: Etoposide
etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle
Other Name: VP-16

Drug: actinomycin D
actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle
Other Names:
  • ACTD
  • Sanamycin

Drug: methotrexate
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
Other Name: MTX

Drug: vincristine
vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle
Other Name: VCR

Drug: cyclophosphamide
cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle
Other Name: CTX
Experimental: study group
paclitaxel + cisplatin or carboplatin，two weeks a cycle
 Drug: Paclitaxel
paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle
Other Name: Taxol

Drug: Cisplatin
cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle
Other Name: DDP

Drug: Carboplatin
carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin
Other Name: CBP


Outcome Measures
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Primary Outcome Measures :
  1. complete remission rate in firstline treatment [ Time Frame: 3 years ]
    We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.


Secondary Outcome Measures :
  1. Severity of adverse events as assessed by the WHO [ Time Frame: 3 years ]
    We calculate the adverse events during and after chemotherapy.

  2. Overall Survival Rate (OR) [ Time Frame: 3 years ]
    We calculate the overall survival rate of high risk GTN patients after chemotherapy.

  3. Ovarian functional evaluation [ Time Frame: every 6 months up to 3 years ]
    We may test serum level of anti-mullerian hormone (AMH) every 6 months and the time of menstrual cycle resuming after chemotherapy.

  4. The pregnancy rate [ Time Frame: 3 years ]
    To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail


Eligibility Criteria
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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • World Health Organization(WHO) risk score ≥7
  • Age≤60 years; female, Chinese women
  • Initial treatment is chemotherapy
  • Performance status: Karnofsky score≥60
  • 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
  • Provide written informed consent.

Exclusion Criteria:

  • Patients with unconfirmed diagnosis of GTN
  • Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
  • WHO risk score 《7
  • With severe or uncontrolled internal disease, unable to receive chemotherapy
  • Concurrently participating in other clinical trials
  • Unable or unwilling to sign informed consents
  • Unable or unwilling to abide by protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639650


Contacts
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Contact: Lu Weiguo, Doctor 86-13588819218 lbwg@zju.edu.cn

Locations
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China, Zhejiang
Weiguo Lv Recruiting
Hangzhou, Zhejiang, China
Contact: Weiguo Lv, Doctor         
Sponsors and Collaborators
Weiguo Lv
Shandong University
Huazhong University of Science and Technology
First Affiliated Hospital of Zhongshan Medical University
More Information
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Responsible Party: Weiguo Lv, Vice-President, Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT02639650    
Other Study ID Numbers: ZJHGTN1211
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Keywords provided by Weiguo Lv, Women's Hospital School Of Medicine Zhejiang University:
gestational trophoblastic tumor
paclitaxel
cisplatin
carboplatin
chemotherapy
Additional relevant MeSH terms:
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Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Pregnancy Complications, Neoplastic
Pregnancy Complications
Dactinomycin
Paclitaxel
Etoposide
Vincristine
Cyclophosphamide
Carboplatin
Methotrexate
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents