Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: xiang yang
• Treatments: Dactinomycin; Leucovorin; Methotrexate

Criteria

Inclusion Criteria:

• Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:

• Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers

• Greater than 20% sustained rise in beta HCG titer over two consecutive weeks

• Histologically proven choriocarcinoma

• Stage I - III disease

• WHO risk score 0-4

• No prior chemotherapy for gestational trophoblastic neoplasia

• Signed informed consent

• Performance status - GOG 0-2

• Laboratory examination： WBC≥3.5×10(9)/L, Granulocyte count≥1.5×10(9)/L, Platelet count≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Creatinine≤ normal。 Fertile patients must use effective contraception during and for one year after study entry

Exclusion Criteria:

• Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)

• primary choriocarcinoma

• WHO risk score >4

• Previous MTX treatment for suspected ectopic pregnancy

• With severe or uncontrolled internal disease, unable to receive chemotherapy;

• Concurrently participating in other clinical trials

• Unable or unwilling to sign informed consents;

• Unable or unwilling to abide by protocol.