The investigators conducted a randomized trial to study how well multi-day methotrexate protocol works compared to biweekly single-dose actinomycin D protocol in treating patients with low-risk gestational trophoblastic neoplasia. It is not yet known whether multi-day methotrexate protocol is as effective as biweekly single-dose actinomycin D protocol in treating patients with gestational trophoblastic neoplasia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days
15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days
1.25mg/m2 (2mg max dose)intravenous every 14 days.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Completely remission (CR) rate by single-agent
Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.
Time frame: from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy,assessed up to 8 months
Overall completely remission rate
Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure
Time frame: from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy or multi-agent chemotherapy,assessed up to 12 months
The duration needed to achieve complete remission after single-agent chemotherapy
The duration needed to achieve complete remission after single-agent in two arms
Time frame: from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy,assessed up to 8 months
The number of courses needed to achieve complete remission after single-agent chemotherapy
The number of courses needed to achieve complete remission after single-agent chemotherapy in two arms
Time frame: from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy,assessed up to 8 months
Incidence of Adverse Effects (Grade 3 or Higher)
Incidence and severity of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 in two arms
Time frame: through study completion, an average of 3 year
Effects on menstrual conditions and ovarian function
Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone(AMH)
Time frame: Prior to treatment begin,and 6 month after single-agent chemotherapy completion, an average of 2 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.