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

Gestational Trophoblastic Neoplasms Clinical Trial

Official title:

A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02639650
• Other study ID #: ZJHGTN1211
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2016
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Lu Weiguo, Doctor
• Phone: 86-13588819218
• Email: lbwg[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 60 Years

Eligibility

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 ? cases

• World Health Organization(WHO) risk score =7, and less than 13

• 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 less than 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

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasms
• Trophoblastic Neoplasms

Intervention

Drug:
• Etoposide
etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle
• actinomycin D
actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle
• 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
• vincristine
vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle
• cyclophosphamide
cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle
• Paclitaxel
paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle
• Cisplatin
cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle
• 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

Locations

Country	Name	City	State
China	Weiguo Lv	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Weiguo Lv	First Affiliated Hospital of Zhongshan Medical University, Huazhong University of Science and Technology, Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate in firstline treatment	We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.	3 years
Secondary	Severity of adverse events as assessed by the WHO	We calculate the adverse events during and after chemotherapy.	3 years
Secondary	Overall Survival Rate (OR)	We calculate the overall survival rate of high risk GTN patients after chemotherapy.	3 years
Secondary	Ovarian functional evaluation	We may test serum level of anti-mullerian hormone (AMH) every 6 months and the time of menstrual cycle resuming after chemotherapy.	every 6 months up to 3 years
Secondary	The pregnancy rate	To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail	3 years