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Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

NCT01535053 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2022-08-12

Study results available
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Summary

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

Conditions

  • Choriocarcinoma
  • FIGO Stage I Gestational Trophoblastic Tumor
  • FIGO Stage II Gestational Trophoblastic Tumor
  • FIGO Stage III Gestational Trophoblastic Tumor
  • Hydatidiform Mole

Interventions

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Leucovorin Calcium

Given PO

DRUG

Methotrexate

Given IV and IM

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • GOG Foundation

    lead NETWORK

Principal Investigators

  • Julian C Schink · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-18
Primary Completion
2018-05-31
Completion
2020-07-17

Countries

  • United States
  • Canada
  • Japan
  • South Korea
  • United Kingdom

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 NCT01535053 on ClinicalTrials.gov