Trial name or title	Methotrexate or dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia (NCT01535053)
Methods	Multicentre phase III RCT; open label
Participants	384
Interventions	Arm I: methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single to agent methotrexate IV on days 1 to 5 Arm II: dactinomycin IV over 15 minutes on day 1. Cycles repeated every 14 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Women receive 3 courses after hCG < 5 mIU/Ml
Outcomes	Primary: Complete response rate Secondary: post protocol surgery; post-protocol multi-agent treatment; severe adverse events; QoL
Starting date	January 2012. Estimated completion August 2016
Contact information	Dr Julian Schink Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, United States, 60611 Ph: 312-472-4684
Notes

IM = intramuscular; IV = intravenous; PO = by mouth; QoL = quality of life; RCT = randomised controlled trial