CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 57 enrolled
Drug / intervention
Dactinomycin +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01535053
NCT01535053Phase 3Completed

A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia

GOG Foundation·interventional·Posted Feb 17, 2012·Updated Aug 12, 2022

In Brief

A Phase 3 clinical trial evaluating Dactinomycin, Leucovorin Calcium, and 2 other interventions for Choriocarcinoma and 4 related conditions. Completed, enrolled 57 participants across 289 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Japan, South Korea, United Kingdom, United States

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2012
Enrollment StartJun 18, 2012
Primary CompletionMay 31, 2018
Study CompletionJul 17, 2020
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 14.4 years ago

Interventions

Dactinomycinbiological

Given IV

Leucovorin Calciumdrug

Given PO

Methotrexatedrug

Given IV and IM

Quality-of-Life Assessmentother

Ancillary studies