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


Phase 3
18 Years
60 Years
Open (Enrolling)
Female
Gestational Trophoblastic Disease, Gestational Trophoblastic Neoplasia, Gestational Trophoblastic Tumor, Gestational Trophoblastic Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Severity of adverse events as assessed by the WHO

Outcome Description:

It is difficult to estimate the exact cycles of chemotherapy,we may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Xing Xie, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Zhejiang University

Authority:

China: Ministry of Health

Study ID:

2012-GYN/GTN-01

NCT ID:

NCT01823315

Start Date:

December 2012

Completion Date:

December 2017

Related Keywords:

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

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