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Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6

NCT03885388 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-03-21

No results posted yet for this study

Summary

In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen.

Conditions

  • Gestational Trophoblastic Tumor
  • Effects of Chemotherapy
  • Drug Toxicity

Interventions

DRUG

MTX

multicourse methotrexate chemotherapy

DRUG

MTX+ACTD

combination use of methotrexate and actinomycin

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • West China Second University Hospital

    collaborator OTHER

  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Principal Investigators

  • Weiguo Lu, MD. · Women's Hospital, College of Medicine Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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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 NCT03885388 on ClinicalTrials.gov