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

Condition(s) targeted: Gestational Trophoblastic Disease; Gestational Trophoblastic Neoplasia; Gestational Trophoblastic Tumor; Gestational Trophoblastic Neoplasms

Intervention: MTX 1 (Drug); MTX 2 (Drug); Act-d (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ding Ma

Official(s) and/or principal investigator(s):
Xing Xie, MD, PhD, Study Chair, Affiliation: Zhejiang University

Overall contact:
Danhui Weng, MD, PhD, Phone: +862783662681, Email: weng.dh@gmail.com

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.

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

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

Primary outcome:

Severity of adverse events as assessed by the WHO

Progression-Free Survival (PFS)

Complete response vs treatment failure

Secondary outcome:

Resume menstruation

The pregnancy rate

the delivery rate with at least one live born baby

The incidence of abnormal pregnancy

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Female.

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.

Danhui Weng, MD, PhD, Phone: +862783662681, Email: weng.dh@gmail.com

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China; Recruiting
Danhui Weng, MD, Phone: +862783662681, Email: weng.dh@gmail.com
Ling Xi, MD, Principal Investigator

Qilu Hospital，Shandong University, Jinan, Shandong 250012, China; Recruiting
Jie Jiang, MD, Ph D, Phone: 13791123139, Email: qljiangjie@yahoo.cn
Jie Jiang, MD, Principal Investigator

Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310006, China; Recruiting
Lili Chen, MD, Phone: 13958138597, Email: chenglili-@163.com
Lili Chen, MD, Principal Investigator

Starting date: December 2012
Last updated: March 29, 2013