Spots Global Cancer Trial Database for Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

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Trial Identification

Brief Title: Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

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

Study ID: NCT04756713

Conditions

Gestational Trophoblastic Neoplasia

Molar Pregnancy

Gestational Trophoblastic Tumor, Non-Metastatic

Interventions

Uterine curettage

Chemotherapy

Study Description

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

Detailed 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.