drugset / Trial / NCT04756713
Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia
Phase 3
Unknown
150 enrolled
Brigham and Women's Hospital
Campinas State University UNICAMP · collabFederal University of Ceará · collabFederal University of São Paulo · collabMaternidade Escola da Universidade Federal do Rio de Janeiro · collabMedical School of Santa Casa da Misericórdia de Porto Alegr · collabPaulista State University UNESP BOTUCATU · collabUniversidade Federal do Rio de Janeiro · collabUniversity of Caxias do Sul · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.
Timeline
- Start
- 2021-02-11
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
Publications
- Background Osborne RJ, Filiaci VL, Schink JC, Mannel RS, Behbakht K, Hoffman JS, Spirtos NM, Chan JK, Tidy JA, Miller DS. Second Curettage for Low-Risk Nonmetastatic Gestational Trophoblastic Neoplasia. Obstet Gynecol. 2016 Sep;128(3):535-542. doi: 10.1097/AOG.0000000000001554.
- Background Hemida R, Vos EL, El-Deek B, Arafa M, Toson E, Burger CW, van Doorn HC. Second Uterine Curettage and the Number of Chemotherapy Courses in Postmolar Gestational Trophoblastic Neoplasia: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):1024-1031. doi: 10.1097/AOG.0000000000003232.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | — | — |
| Comparator | Dactinomycin | Protein / enzyme biologic | 1.25 mg | Intravenous |
| Comparator | E | Unknown | — | — |
| Comparator | Methotrexate | Small molecule | 1 mg/kg | Intramuscular |
| Comparator | Leucovorin | Small molecule | 15 mg | Oral |