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

Ding Ma300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Gestational Trophoblastic Disease Gestational Trophoblastic Neoplasia Gestational Trophoblastic Tumor Gestational Trophoblastic Neoplasms

Interventions

MTX 1DRUG

MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5

MTX 2DRUG

MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, \>4h)

Act-dBIOLOGICAL

Act-d 0.6mg/m(2), IV, on day1,2

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (3)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Qilu Hospital，Shandong University

Jinan, Shandong, China

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China