Comparing two treatments for low-risk gestational trophoblastic neoplasia
A Prospective，Multicenter，Randomized Trial of Biweekly Single-dose Actinomycin-D Versus Multi-day Methotrexate Protocol for the Treatment of Low-risk Gestational Trophoblastic Neoplasia
This study is testing whether a multi-day treatment with methotrexate works better than a biweekly single-dose of actinomycin D for people with low-risk gestational trophoblastic neoplasia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04562558 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a multi-day methotrexate protocol versus a biweekly single-dose actinomycin D protocol in treating patients with low-risk gestational trophoblastic neoplasia. Participants are randomly assigned to receive either treatment to determine which is more effective in managing their condition. The study focuses on patients with specific histological criteria and stages of gestational trophoblastic tumors. The goal is to establish a more effective treatment regimen for this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically proven low-risk gestational trophoblastic neoplasia who have not received prior chemotherapy.
Not a fit: Patients with histologically confirmed placental-site trophoblastic tumor or epithelioid trophoblastic tumor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with low-risk gestational trophoblastic neoplasia.
How similar studies have performed: Other studies have explored treatments for gestational trophoblastic neoplasia, but this specific comparison of methotrexate and actinomycin D is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yang Xiang
- Email: xiangy@Pumch.cn
- Phone: 86-010-69155635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.