Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia
Gestational Trophoblastic Tumor, Gestational Trophoblastic Neoplasia, Stage I Gestational Trophoblastic Tumor
About this trial
This is an interventional treatment trial for Gestational Trophoblastic Tumor focused on measuring gestational trophoblastic neoplasia, actinomycin-D, methotrexate, low-risk
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm1-Methotrexate
Arm 2-Dactinomycin
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.
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.