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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1-Methotrexate | Experimental | 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. |
|
| Arm 2-Dactinomycin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The duration needed to achieve complete remission after single-agent chemotherapy | The duration needed to achieve complete remission after single-agent in two arms | 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 |
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Inclusion Criteria:
Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| yang xiang | Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40543844 | Derived | Jiang 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. | |
| 40382972 |
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A prospective，multicenter，randomized trial with two arms
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| Leucovorin | Drug | 15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days |
|
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| Dactinomycin | Drug | 1.25mg/m2 (2mg max dose)intravenous every 14 days. |
|
|
| 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 |
| 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 | 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） | Prior to treatment begin，and 6 month after single-agent chemotherapy completion, an average of 2 year |
| Derived |
| Gouveia 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. |
| 37612621 | Derived | Jiang 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. |
| ID | Term |
|---|---|
| D031901 | Gestational Trophoblastic Disease |
| D002820 | Hydatidiform Mole, Invasive |
| D002822 | Choriocarcinoma |
| ID | Term |
|---|---|
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006828 | Hydatidiform Mole |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D002955 | Leucovorin |
| D003609 | Dactinomycin |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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