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Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia — ReCure  

Gestational Trophoblastic Neoplasia Clinical Trial

Official title:
Impact of Second Uterine Evacuation in Women With Non-metastatic, Low-risk Gestational Trophoblastic Neoplasia: A Phase III Trial

Clinical Trial Summary

To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.

Clinical Trial Description

This is a randomized, multicenter clinical trial including patients seen at one of 13 gestational trophoblastic disease reference centers in Brazil. Subjects are eligible if they have low-risk gestational trophoblastic neoplasia according to FIGO 2000 criteria and the FIGO/WHO prognostic risk score. The study includes two treatment arms: immediate treatment with single-agent chemotherapy (center choice of agent) or second uterine curettage. The primary outcome is the rate of primary remission. Secondary outcomes are the number of chemotherapy cycles required to achieve remission, rate of primary chemotherapy resistance, rate of relapse, and overall survival. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04756713
Study type Interventional
Source Brigham and Women's Hospital
Contact MARCIO BARCELLOS, MD
Phone (21)2556-9747
Email mbezerrab@yahoo.com.br
Status Recruiting
Phase Phase 3
Start date February 11, 2021
Completion date December 31, 2025
View Details
See also
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Recruiting NCT06028672 - Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6 N/A
Terminated NCT02664961 - Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN) Phase 2
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Recruiting NCT03703271 - Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia Phase 3
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Recruiting NCT05139095 - Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia Phase 2
Recruiting NCT05635344 - A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia Phase 2
Recruiting NCT03785574 - Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule N/A
Active, not recruiting NCT01823315 - Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia Phase 3
Not yet recruiting NCT06169644 - The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment
Recruiting NCT04812002 - Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy Phase 2