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NCT Number: NCT04562558

Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gestational Trophoblastic Tumor Adenocarcinoma Carcinoma Choriocarcinoma Female Urogenital Diseases and Pregnancy Complications Gestational Trophoblastic Disease Gestational Trophoblastic Neoplasia Hydatidiform Mole Hydatidiform Mole, Invasive Invasive Mole Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Pregnancy Complications Pregnancy Complications, Neoplastic Stage I Gestational Trophoblastic Tumor Stage II Gestational Trophoblastic Tumor Stage III Gestational Trophoblastic Tumor Trophoblastic Neoplasms Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methotrexate

Drug

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

Other names: MTX

Leucovorin

Drug

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

Other names: Calcium folinate

Dactinomycin

Drug

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

Other names: dactinomycin D

Primary outcomes

  1. 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

    Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.

  2. Overall completely remission rate

    Time frame: 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

    Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure

Secondary outcomes

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

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

  2. The number of courses needed to achieve complete remission after single-agent chemotherapy

    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 number of courses needed to achieve complete remission after single-agent chemotherapy in two arms

  3. Incidence of Adverse Effects (Grade 3 or Higher)

    Time frame: through study completion, an average of 3 year

    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

  4. Effects on menstrual conditions and ovarian function

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

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

Sponsors and collaborators

Lead sponsor

xiang yang

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Sep 24, 2020
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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