NCT02639650

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Weiguo Lv · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gestational Trophoblastic Neoplasms

Interventions

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

Timeline

• Start date: 2016-03-01
• Primary completion: 2024-03-01
• Completion: 2026-03-01
• First posted: 2015-12-24
• Last updated: 2022-06-03

Locations

1 site across 1 country: China