Clinical Trial: Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter, Prospective, Randomized Trial of Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

Brief Summary: The investigators will conduct a trial to determine whether methotrexate single-dose treatment and methotrexate/Actinomycin-D single-dose treatment work well as multiple courses of single agent chemotherapy in low-risk gestational trophoblastic neoplasia.

Detailed Summary:
Sponsor: Ding Ma

Current Primary Outcome:

  • Severity of adverse events as assessed by the WHO [ Time Frame: 3 years ]
    It is difficult to estimate the exact cycles of chemotherapy，we may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.
  • Progression-Free Survival (PFS) [ Time Frame: 1-year ]
  • Complete response vs treatment failure [ Time Frame: 3 years ]
    It is difficult to estimate the exact cycles of chemotherapy，we may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Resume menstruation [ Time Frame: at the time the first resume menstruation after treatment completed ]
  • The pregnancy rate [ Time Frame: 3 years ]
    to calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail
  • the delivery rate with at least one live born baby [ Time Frame: 3 years ]
    to calculate the delivery rate in an actuarial manner using the Kaplan-Meier method at the end of the trail
  • The incidence of abnormal pregnancy [ Time Frame: 3 years ]
    to observe the incidence of abnormal pregnancy i.e., stillbirths, neonatal deaths, miscarriages before 14 weeks, miscarriages after 14 weeks, terminations, ectopic pregnancy, molar pregnancy.


Original Secondary Outcome: Same as current

Information By: Huazhong University of Science and Technology

Dates:
Date Received: March 21, 2013
Date Started: December 2012
Date Completion: December 2017
Last Updated: October 7, 2016
Last Verified: October 2016