Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

• Status: Active, not recruiting
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators conducted a trial to determine whether methotrexate or methotrexate/dactinomycin single-course treatment work well as multiple courses of single methotrexate chemotherapy in low-risk gestational trophoblastic neoplasia. It is not yet known whether single-course of chemotherapy is as the same effectiveness as multicourse.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ding Ma
• Collaborators: Huazhong University of Science and Technology; Shandong University; Zhejiang University
• Treatments: Dactinomycin; Methotrexate

Criteria

Inclusion Criteria:

• Patients who FIGO Stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN);

• WHO risk score 0-6;

• Age≤60 years; female, Chinese women;

• Initial treatment is chemotherapy; patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study;

• Performance status: Karnofsky score≥60;

• Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal

• Provide written informed consent.

Exclusion Criteria:

• Patients with unconfirmed diagnosis of GTN;

• Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)

• WHO risk score >6;

• 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.