drugset / Trial / NCT01535053

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

NCT01535053

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dactinomycin Protein / enzyme biologic Intravenous
Comparator Methotrexate Small molecule Intravenous
Comparator Leucovorin Small molecule Oral