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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2025
  • participants needed
    176
  • sponsor
    xiang yang
Updated on 25 January 2021
gonadotropin
serum bilirubin

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. 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.

Details
Condition Choriocarcinoma, Invasive hydatidiform mole, Adenocarcinoma, Gestational trophoblastic disease, Stage II Gestational Trophoblastic Tumor, Stage III Gestational Trophoblastic Tumor, Malignant Adenoma, Gestational Trophoblastic Neoplasia, Stage I Gestational Trophoblastic Tumor
Treatment methotrexate, dactinomycin, Leucovorin
Clinical Study IdentifierNCT04562558
Sponsorxiang yang
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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 WBC3.510(9)/L, Granulocyte count1.510(9)/L, Platelet count8010(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
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