Second uterine evacuation for low-risk gestational trophoblastic neoplasia

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

This study is testing whether a second uterine procedure is better than immediate chemotherapy for women with low-risk gestational trophoblastic neoplasia to see which helps them recover more effectively.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sex: Female
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Botucatu and 6 other locations)
• Trial ID: NCT04756713 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a second uterine curettage in patients diagnosed with low-risk non-metastatic gestational trophoblastic neoplasia (GTN). It is a randomized, multicenter trial conducted across 13 reference centers in Brazil, comparing immediate treatment with single-agent chemotherapy to the second uterine curettage approach. The primary outcome is the rate of primary remission, while secondary outcomes include the number of chemotherapy cycles needed, rates of chemotherapy resistance, relapse, and overall survival. Eligible patients must meet specific FIGO criteria for low-risk GTN.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with a histopathological diagnosis of low-risk non-metastatic gestational trophoblastic neoplasia.

Not a fit: Patients with high-risk GTN, metastatic disease, or those who have previously received chemotherapy are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with low-risk GTN, potentially improving remission rates and reducing the need for chemotherapy.

How similar studies have performed: Other studies have explored similar treatment approaches for GTN, but this specific comparison of second curettage versus chemotherapy is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Histopathological diagnosis of molar pegnancy according to the morphological criteria described by Sebire et al., who meet the diagnostic criteria for low-risk non-metastatic GTN according to FIGO 2000 criteria

Exclusion Criteria:

1. High risk GTN (FIGO risk score ≥ 7) or metastatic disease at diagnosis of GTN (stage II, III or IV);
2. Histopathological diagnosis of choriocarcinoma, placental site trophoblastic or epithelioid trophoblastic tumor at the second curettage;
3. Previous chemotherapy treatment;
4. Level of hCG at the time of GTN diagnosis less than 20 IU/L (to minimize the risk of inclusion of patients with false positive hCG, either by cross-reaction with pituitary hormones or by the presence of circulating heterophilic antibodies);
5. Relapsed GTN;
6. Incomplete medical records.
7. Loss to follow-up;
8. Voluntary desire to stop participating in the study.

Where this trial is running

Botucatu and 6 other locations

• Paulista State University UNESP — Botucatu, Brazil (Not_yet_recruiting)
• Campinas State University UNICAMP — Campinas, Brazil (Recruiting)
• University of Caxias do Sul — Caxias Do Sul, Brazil (Recruiting)
• Federal University of Ceará — Ceará, Brazil (Recruiting)
• Medical School of Santa Casa da Misericórdia de Porto Alegre — Porto Alegre, Brazil (Recruiting)
• Maternidade Escola da Universidade Federal do Rio de Janeiro — Rio de Janeiro, Brazil (Recruiting)
• Federal University of São Paulo UNIFESP — São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Marcio Barcellos, Md

Conditions Gestational Trophoblastic Neoplasia; Molar Pregnancy; Gestational Trophoblastic Tumor, Non-Metastatic