MedTrace Logo

Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

NCT04756713 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-05-27

No results posted yet for this study

Summary

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

Conditions

  • Gestational Trophoblastic Neoplasia
  • Molar Pregnancy
  • Gestational 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.

Sponsors & Collaborators

  • Maternidade Escola da Universidade Federal do Rio de Janeiro

    collaborator UNKNOWN

  • Universidade Federal do Rio de Janeiro

    collaborator OTHER

  • Federal University of Ceará

    collaborator UNKNOWN

  • Federal University of São Paulo UNIFESP

    collaborator UNKNOWN

  • Campinas State University UNICAMP

    collaborator UNKNOWN

  • Paulista State University UNESP BOTUCATU

    collaborator UNKNOWN

  • Medical School of Santa Casa da Misericórdia de Porto Alegr

    collaborator UNKNOWN

  • University of Caxias do Sul

    collaborator UNKNOWN

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Antonio Braga, MD, PhD · Maternidade Escola da Universidade Federal do Rio de Janeiro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04756713 on ClinicalTrials.gov