Gestational Trophoblastic TumorGestational Trophoblastic NeoplasiaStage I Gestational Trophoblastic TumorStage II Gestational Trophoblastic TumorStage III Gestational Trophoblastic TumorInvasive MoleChoriocarcinoma
Investigational drug(s) / intervention(s)
MethotrexateLeucovorinDactinomycin
Methotrexate: 50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days
Leucovorin: 15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days
Dactinomycin: 1.25mg/m2 (2mg max dose)intravenous every 14 days.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Completely remission (CR) rate by single-agent — 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.
Overall completely remission rate — 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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