Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
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ClinicalTrials.gov Identifier: NCT02639650 |
Recruitment Status :
Recruiting
First Posted : December 24, 2015
Last Update Posted : October 4, 2018
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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 |
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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: control group
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
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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:
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 |
- 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.
- Severity of adverse events as assessed by the WHO [ Time Frame: 3 years ]We calculate the adverse events during and after chemotherapy.
- Overall Survival Rate (OR) [ Time Frame: 3 years ]We calculate the overall survival rate of high risk GTN patients after chemotherapy.
- 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.
- 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

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

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
Contact: Lu Weiguo, Doctor | 86-13588819218 | lbwg@zju.edu.cn |
China, Zhejiang | |
Weiguo Lv | Recruiting |
Hangzhou, Zhejiang, China | |
Contact: Weiguo Lv, Doctor |
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 |
gestational trophoblastic tumor paclitaxel cisplatin carboplatin chemotherapy |
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 |