drugset / Trial / NCT01823315
Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
Phase 3
Unknown
300 enrolled
Ding Ma
Huazhong University of Science and Technology · collabShandong University · collabZhejiang University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-12
- Primary completion
- 2015-12
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dactinomycin | Protein / enzyme biologic | 0.6 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 0.4 mg/kg | Intramuscular |
| Subject | Methotrexate | Small molecule | 100 mg/m2 | Intramuscular |
| Subject | Methotrexate | Small molecule | 200 mg/m2 | Intramuscular |