Clinical Trial: Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

Brief Summary: This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.

Detailed Summary:
Sponsor: Weiguo Lv

Current Primary Outcome: complete remission rate in firstline treatment [ Time Frame: 2 years ]

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:

  • Severity of adverse events as assessed by the WHO [ Time Frame: 3 years ]
  • Overall Survival Rate (OR) [ Time Frame: 3 years ]
  • Ovarian functional evaluation [ Time Frame: 3 years ]
    We may record the age of menopause to evaluate the the function of ovary
  • Ovarian functional evaluation [ Time Frame: every 6 months up to 3 years ]
    We may test serum level of anti-mullerian hormone (AMH) every 6 months
  • Ovarian functional evaluation [ Time Frame: 3 years ]
    We may record the time of menstrual cycle resuming after chemotherapy
  • 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


Original Secondary Outcome: Same as current

Information By: Women's Hospital School Of Medicine Zhejiang University

Dates:
Date Received: December 13, 2015
Date Started: March 2016
Date Completion: March 2021
Last Updated: December 20, 2015
Last Verified: December 2015