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

NCT02639650 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2022-06-03

No results posted yet for this study

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.

Conditions

  • Gestational Trophoblastic Neoplasms

Interventions

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

Sponsors & Collaborators

  • Shandong University

    collaborator OTHER

  • Huazhong University of Science and Technology

    collaborator OTHER

  • First Affiliated Hospital of Zhongshan Medical University

    collaborator OTHER

  • Weiguo Lv

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2024-03-01
Completion
2026-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02639650 on ClinicalTrials.gov