NCT01823315.

Trial name or title	Methotrexate single‐dose treatment and methotrexate/actinomycin‐D single‐dose treatment in low‐risk gestational trophoblastic neoplasia (GTN‐01)
Methods	Open‐label RCT in China; 3‐year follow‐up
Participants	300 women with LRGTN
Interventions	Arm 1: MTX 0.4 mg/(kg·day) IM on days 1‐5. If BhCG level can not drop to 1/10 of the origin level during the following 3 weeks, additional course is administered at 2‐week intervals, after the first normal hCG value has been recorded. Arm 2: Act D 0.6 mg/m2, IV on day 1,2; MTX 100 mg/m2, IV, on day1 (after Act D); MTX 200 mg/m2, IV, on day 1 (after MTX, 500 mL NS > 4 hours) If BhCG level does not drop to 1/10 of the origin level during the following 3 weeks, additional courses are administered at 2‐week intervals, with one additional cycle after the first normal hCG value has been recorded.
Outcomes	Primary: adverse events; progression‐free survival, CR and treatment failure Secondary: resumption of menstruation, pregnancy rate, delivery rate of live‐born babies, abnormal pregnancy (stillbirth, neonatal deaths, miscarriage, terminations, ectopic and molar pregnancies)
Starting date	December 2012. Estimated completion date December 2017
Contact information	Dr Danhui Weng Tongji Hospital, Wuhan, Hubei, China, 430030
Notes

Act D = Actinomycin D; BhCG = beta human chorionic gonadotrophin; CR = Complete response; CT = chemotherapy; FIGO = International Federation of Gynecology and Obstetrics; IM = intramuscular; IV = intravenous; LRGTN = low‐risk gestational trophoblastic neoplasia; MTX = Methotrexate; NS = normal saline; PO = by mouth; QoL = quality of life; RCT = randomised controlled trial; WHO = World Health Organization