Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

PHASE3RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

February 11, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Gestational Trophoblastic NeoplasiaMolar PregnancyGestational Trophoblastic Tumor, Non-Metastatic
Interventions
PROCEDURE

Uterine curettage

Manual or electric vacuum aspiration under ultrasound guidance.

DRUG

Chemotherapy

conventional chemotherapy will be treated with MTX (1 mg/kg intramuscular) with rescue of FA (15mg orally). In cases of chemoresistance, second-line chemotherapy will be performed with actinomycin-D (Act-D) 1.25 mg intravenous pulse every 14 days. The third line of chemotherapy will be the EMA/CO regimen (, reserving the EP / EMA regimen (E, cisplatin, MTX / Act-D) for the fourth line.

Trial Locations (7)

Unknown

NOT_YET_RECRUITING

Paulista State University UNESP, Botucatu

RECRUITING

Campinas State University UNICAMP, Campinas

RECRUITING

University of Caxias do Sul, Caxias do Sul

RECRUITING

Federal University of Ceará, Ceará

RECRUITING

Medical School of Santa Casa da Misericórdia de Porto Alegre, Porto Alegre

RECRUITING

Maternidade Escola da Universidade Federal do Rio de Janeiro, Rio de Janeiro

RECRUITING

Federal University of São Paulo UNIFESP, São Paulo

All Listed Sponsors
collaborator

Maternidade Escola da Universidade Federal do Rio de Janeiro

UNKNOWN

collaborator

Universidade Federal do Rio de Janeiro

OTHER

collaborator

Federal University of Ceará

UNKNOWN

collaborator

Federal University of São Paulo UNIFESP

UNKNOWN

collaborator

Campinas State University UNICAMP

UNKNOWN

collaborator

Paulista State University UNESP BOTUCATU

UNKNOWN

collaborator

Medical School of Santa Casa da Misericórdia de Porto Alegr

UNKNOWN

collaborator

University of Caxias do Sul

UNKNOWN

lead

Brigham and Women's Hospital

OTHER

NCT04756713 - Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia | Biotech Hunter | Biotech Hunter