Overview

This trial is active, not recruiting.

Conditions gestational trophoblastic disease, gestational trophoblastic neoplasia, gestational trophoblastic tumor, gestational trophoblastic neoplasms
Treatments mtx 1, mtx 2, act-d
Phase phase 3
Sponsor Ding Ma
Collaborator Zhejiang University
Start date December 2012
End date December 2015
Trial size 300 participants
Trial identifier NCT01823315, 2012-GYN/GTN-01

Summary

The investigators will conduct a trial to determine whether methotrexate single-dose treatment and methotrexate/Actinomycin-D single-dose treatment work well as multiple courses of single agent chemotherapy in low-risk gestational trophoblastic neoplasia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Methotrexate (MTX) 0.4mg/(kg·d) intramuscularly (IM) on days 1-5; If β-hCG level can not drop to 1/10 of the origin level during the following 3 weeks, additional course is administered at 2-week intervals, after the first normal hCG value has been recorded.
mtx 1
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5
(Experimental)
Act-d 0.6mg/m(2), IV, on day1,2; MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h); If β-hCG level can not drop to 1/10 of the origin level during the following 3 weeks, additional course is administered at 2-week intervals, after the first normal hCG value has been recorded.
mtx 2
MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h)
act-d
Act-d 0.6mg/m(2), IV, on day1,2
(Active Comparator)
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5, 2-week intervals; 1 cycle of chemotherapy should be given after the first normal hCG level.
mtx 1
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5

Primary Outcomes

Measure
Severity of adverse events as assessed by the WHO
time frame: 3 years
Progression-Free Survival (PFS)
time frame: 1-year
Complete response vs treatment failure
time frame: 3 years

Secondary Outcomes

Measure
Resume menstruation
time frame: at the time the first resume menstruation after treatment completed
The pregnancy rate
time frame: 3 years
the delivery rate with at least one live born baby
time frame: 3 years
The incidence of abnormal pregnancy
time frame: 3 years

Eligibility Criteria

Female participants from 18 years up to 60 years old.

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.

Additional Information

Official title A Multicenter, Prospective, Randomized Trial of Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Huazhong University of Science and Technology.