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Gestational Trophoblastic TumorNCT04562558

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

A study testing Methotrexate, Leucovorin and Dactinomycin in people with Gestational Trophoblastic Tumor and Gestational Trophoblastic Neoplasia, run by xiang yang at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Methotrexate, Leucovorin and Dactinomycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
1 siteChina
Study dates
29 Sep 2020to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: 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

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.

Being tested
Methotrexate, Leucovorin, Dactinomycin
Keywords
gestational trophoblastic neoplasia, actinomycin-D, methotrexate, low-risk
Medical subject headings
Gestational Trophoblastic Disease, Hydatidiform Mole, Invasive, Choriocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    Also called MTX

    50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days

  • LeucovorinDrug

    Also called Calcium folinate

    15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days

  • DactinomycinDrug

    Also called dactinomycin D

    1.25mg/m2 (2mg max dose)intravenous every 14 days.

Study groups in NCT04562558
Study groupRoleWhat they receive
Arm1-MethotrexateExperimentalPatients 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.
Receives: Drug: Methotrexate; Drug: Leucovorin
Arm 2-DactinomycinExperimentalPatients 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.
Receives: Drug: Dactinomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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

    Measured: 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

Secondary outcomes (4)

  1. The duration needed to achieve complete remission after single-agent chemotherapy

    The duration needed to achieve complete remission after single-agent in two arms

    Measured: 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

  2. 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

    Measured: 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

  3. 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

    Measured: through study completion, an average of 3 year

  4. Effects on menstrual conditions and ovarian function

    Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone（AMH）

    Measured: Prior to treatment begin，and 6 month after single-agent chemotherapy completion, an average of 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2020
  2. Study start29 Sep 2020
  3. Primary completion11 Nov 2024
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective，multicenter，randomized trial with two arms
Masking
None (open label)
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04562558
Sponsor's protocol ID
PUMCH-LRGTN-SINGLE DRUG-0222
Status last verified
Aug 2025
First submitted
13 Sep 2020
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40543844

  • 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.

    PubMed 40382972

  • 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.

    PubMed 37612621

Questions about this trial

What is this clinical trial studying?

A study testing Methotrexate, Leucovorin and Dactinomycin in people with Gestational Trophoblastic Tumor and Gestational Trophoblastic Neoplasia, run by xiang yang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completely remission (CR) rate by single-agent (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04562558, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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