Actinomycin-D vs Methotrexate for treatment of low risk GTN
Research type
Research Study
Full title
A Phase III Randomised Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the treatment of low risk Gestational Trophoblastic Neoplasia
IRAS ID
124323
Contact name
Robert Coleman
Contact email
Sponsor organisation
Gynaecological Oncology Group (GOG)
Eudract number
2013-000396-32
Clinicaltrials.gov Identifier
Research summary
GTN is a group of rare tumours that involves abnormal growth of cells inside a woman's uterus. These tumours start in cells called trophoblasts that would normally develop into the placenta during pregnancy. Trophoblastic cells of both normal placentas and GTN make a hormone called human chorionic gonadotropin (hCG) which is vital in supporting a pregnancy. Because GTN tumours usually release more hCG than a normal placenta, measuring hCG blood levels is helpful in determining if GTN is present and if treatment is working. While most GTNs are non-cancerous, some do develop into cancer. All forms can be treated, and treatment almost always results in a cure. Disease that persists after initial therapy but has not spread is usually treated with the drugs, methotrexate or actinomycin-D. Both drugs are effective in treating GTN, but they differ on how the drugs are given, how often the drugs are given, and the side effects. The purpose of this study is to compare intravenous actinomycin-D every two weeks with multi-day intramuscular methotrexate and folinic acid rescue (days 1,3,5,7 every two weeks) to find out which works better to control GTN with the fewest side effects and least interruption of normal daily living.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0162
Date of REC Opinion
25 Jun 2014
REC opinion
Further Information Favourable Opinion