Clinical trial · Interventional
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in 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
NCT04562558CI-TRIAL-00093406active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choriocarcinoma | Choriocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Gestational Trophoblastic Neoplasia | Gestational Trophoblastic Tumor | ALIAS | 0.90 |
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
| Invasive Mole | Invasive Hydatidiform Mole | ALIAS | 0.90 |
| Stage I Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | CURATED_BROADER | 0.78 |
| Stage II Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | CURATED_BROADER | 0.78 |
| Stage III Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dactinomycin | Drug | Dactinomycin | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm1-Methotrexate
- description
- Patients receive methotrexate intramuscularly（50mg） on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment. If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.
- interventionNames
- Drug: Methotrexate
- Drug: Leucovorin
- type
- EXPERIMENTAL
- label
- Arm 2-Dactinomycin
- description
- Patients will receive IV pulse actinomycin-D (1.25mg/m2，2mg max dos) every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment.If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDJiang F, Guan CL, Jiao LZ, Xu T, Wan XR, Shi SS, Wu BB, Zhang X, Zhen L, Miao JW, Tian M, Du M, Li C, Feng FZ, Yang JJ, Ren T, Zhao J, Li Y, Zhang XQ, Lu X, Xiang Y. Efficacy and safety of biweekly single-dose actinomycin D versus multiday methotrexate in low-risk gestational trophoblastic neoplasia: a prospective multicenter randomized trial. Ann Oncol. 2025 Oct;36(10):1123-1131. doi: 10.1016/j.annonc.2025.06.006. Epub 2025 Jun 19. PMID 40543844
- DERIVEDGouveia MC, Vasconcellos JM, Leis LV, Scaranti M. When Impact Multiplies: Defining Trials and Insights from the 2025 Society of Gynecologic Oncology Annual Meeting. Int J Gynecol Cancer. 2025 Jul;35(7):101895. doi: 10.1016/j.ijgc.2025.101895. Epub 2025 Apr 22. PMID 40382972
- DERIVEDJiang F, Mao MY, Xiang Y, Lu X, Guan CL, Jiao LZ, Wan XR, Feng FZ, Ren T, Yang JJ, Zhao J. Comparing biweekly single-dose actinomycin D with multiday methotrexate therapy for low-risk gestational trophoblastic neoplasia (FIGO Score 0-4): study protocol for a prospective, multicentre, randomized trial. BMC Cancer. 2023 Aug 23;23(1):784. doi: 10.1186/s12885-023-11225-2. PMID 37612621