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Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

NCT01823315 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-12-24

No results posted yet for this study

Summary

The investigators conducted a trial to determine whether methotrexate or methotrexate/dactinomycin single-course treatment work well as multiple courses of single methotrexate chemotherapy in low-risk gestational trophoblastic neoplasia. It is not yet known whether single-course of chemotherapy is as the same effectiveness as multicourse.

Conditions

  • Gestational Trophoblastic Disease
  • Gestational Trophoblastic Neoplasia
  • Gestational Trophoblastic Tumor
  • Gestational Trophoblastic Neoplasms

Interventions

DRUG

MTX 1

MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5

DRUG

MTX 2

MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, \>4h)

BIOLOGICAL

Act-d

Act-d 0.6mg/m(2), IV, on day1,2

Sponsors & Collaborators

  • Zhejiang University

    collaborator OTHER

  • Huazhong University of Science and Technology

    collaborator OTHER

  • Shandong University

    collaborator OTHER

  • Ding Ma

    lead OTHER

Principal Investigators

  • Xing Xie, MD, PhD · 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
2012-12-31
Primary Completion
2015-12-31
Completion
2019-12-31

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 NCT01823315 on ClinicalTrials.gov