drugset / Trial / NCT03885388
Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6
Phase 2/3
Unknown
300 enrolled
Women's Hospital School Of Medicine Zhejiang University
Huazhong University of Science and Technology · collabQilu Hospital of Shandong University · collabWest China Second University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen.
Timeline
- Start
- 2019-03-08
- Primary completion
- 2021-12-31
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Actinomycin | Unknown | 0.6 mg/m2 | Intravenous |
| Comparator | MTX | Unknown | 0.4 mg/kg | Intramuscular |
| Comparator | MTX | Unknown | 100 mg/m2 | Intramuscular |
| Comparator | MTX | Unknown | 200 mg/m2 | Intramuscular |