Trials / Unknown
UnknownNCT04756713
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-02-11
- Primary completion
- 2024-12-31
- Completion
- 2025-12-31
- First posted
- 2021-02-16
- Last updated
- 2022-05-27
Locations
7 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04756713. Inclusion in this directory is not an endorsement.