drugset / Trial / NCT03280979

Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia

NCT03280979

Phase 2/3 Unknown 170 enrolled Assiut University
RandomizedParallel-groupOpen-labelTreatment

Summary

Gestational trophoblastic neoplasia (GTN) are malignant lesions that arise from abnormal proliferation of placental trophoblast. The pathologic conditions that make up this entity include invasive partial and complete hydatidiform mole, choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT). GTN often arises after molar pregnancies but can also occur after any gestation including miscarriages and term pregnancies. In the United States, hydatidiform moles are observed in approximately 1/600 therapeutic abortions and 1/1000-2000 pregnancies . Most cases of GTN are diagnosed when the serum hCG levels plateau or rise in patients being observed after the diagnosis of hydatidiform mole.These malignancies are highly susceptible to chemotherapy and it is often possible to achieve cure while preserving the woman's reproductive function

Timeline

Start
2017-10
Primary completion
2019-07
Completion
2019-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 1 mg/kg Intramuscular
Subject Methotrexate Small molecule 200 mg/m2 Intramuscular
Background Leucovorin Small molecule 0.1 mg/kg Intramuscular