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

A Multicenter, Prospective, Randomized Trial of Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01823315

Acronym

GTN-01

Enrollment

300

Registered

2013-04-04

Start date

2012-12-31

Completion date

2019-12-31

Last updated

2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DRUGMTX 1

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

DRUGMTX 2

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

BIOLOGICALAct-d

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Complete response (CR) by single-course	through study completion, an average of 1 year
Completely remission rate by multiple courses after single-course failure	through study completion, an average of 1 year

Secondary

Measure	Time frame
remission rate of ACTD replacement after MTX resistance	through study completion, an average of 1 year
the number of courses needed to achieve complete remission after multi-course treatment	through study completion, an average of 1 year
complete remission rate by multidrug combination therapy after single drug failure	through study completion, an average of 1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026