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

Launched by XIANG YANG · Sep 18, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for women with low-risk gestational trophoblastic neoplasia, a type of tumor that can occur after pregnancy. The researchers want to see if a multi-day treatment with methotrexate is as effective as a biweekly treatment with actinomycin D. Both treatments aim to help manage the tumor, but it’s not yet clear which one works better.

To participate in this study, women aged between 18 and 65 who have been diagnosed with low-risk gestational trophoblastic neoplasia may be eligible, especially if they have not received any prior chemotherapy for this condition. Participants will be randomly assigned to one of the two treatment groups. Throughout the trial, they can expect regular check-ups and monitoring to track their health and response to treatment. It’s important to note that women who can become pregnant will need to use effective birth control during and for a year after the study. This trial is currently recruiting participants, so it’s a great opportunity for eligible women to contribute to important research in this area.

Gender

FEMALE

Eligibility 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.