Status:
UNKNOWN
Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
Lead Sponsor:
Ding Ma
Collaborating Sponsors:
Zhejiang University
Huazhong University of Science and Technology
Conditions:
Gestational Trophoblastic Disease
Gestational Trophoblastic Neoplasia
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01823315
Start Date
December 1 2012
End Date
December 1 2019
Last Update
December 24 2019
Active Locations (3)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
2
Qilu Hospital，Shandong University
Jinan, Shandong, China, 250012
3
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310006