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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: control group
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
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
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
vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle
Other Name: VCR
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
paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle
Other Name: Taxol
cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle
Other Name: DDP
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
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, Doctoremail@example.com|
|Hangzhou, Zhejiang, China|
|Contact: Weiguo Lv, Doctor|