Clinical trial · Interventional
Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia
Comparison Between Rescue Regimen and High Dose Methotrexate in the Managment of Presistent Gestational Trophoplastic Neoplasia :( A Randomized Controlled Trial )
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gestational Trophoblastic Disease | Gestational Trophoblastic Tumor | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high dose methotrxate | Drug | — | UNRESOLVED |
| rescue regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- study group1
- description
- In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of MTX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days.
- interventionNames
- Drug: rescue regimen
- type
- EXPERIMENTAL
- label
- study group2
- description
- In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid
- interventionNames
- Drug: high dose methotrxate
Primary outcomes (1)
- measure
- cure rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-50 * BW: 50-100 kg * willing and consenting to be enrolled in the study * Absence of active vaginal bleeding which requires surgical intervention • - WHO score \<6 Exclusion Criteria: * Renal and liver dysfunction or blood dyscariasis * high risk persistent gestational trophoblastic disease.
References
Publications (0)
Data not yet available