Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia (ReCure)
Gestational Trophoblastic Neoplasia, Molar Pregnancy, Gestational Trophoblastic Tumor, Non-Metastatic
About this trial
This is an interventional treatment trial for Gestational Trophoblastic Neoplasia
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:
- High risk GTN (FIGO risk score ≥ 7) or metastatic disease at diagnosis of GTN (stage II, III or IV);
- Histopathological diagnosis of choriocarcinoma, placental site trophoblastic or epithelioid trophoblastic tumor at the second curettage;
- Previous chemotherapy treatment;
- 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);
- Relapsed GTN;
- Incomplete medical records.
- Loss to follow-up;
- Voluntary desire to stop participating in the study.
Sites / Locations
- Paulista State University UNESP
- Campinas State University UNICAMPRecruiting
- University of Caxias do SulRecruiting
- Federal University of CearáRecruiting
- Medical School of Santa Casa da Misericórdia de Porto AlegreRecruiting
- Maternidade Escola da Universidade Federal do Rio de JaneiroRecruiting
- Federal University of São Paulo UNIFESPRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Chemotherapy
Uterine evacuation
Patients allocated to receive conventional chemotherapy will be treated with methotrexate (1 mg/kg intramuscular) with rescue of folinic acid (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.
Patients randomized to undergo a second curettage will undergo manual or electronic vacuum aspiration under ultrasound guidance. Following discharge after the second curettage patients will return to weekly hCG monitoring. If hCG levels are decreasing, patients will remain on weekly hCG follow-up until the first normal hCG (<5 IU/L) is achieved. Then they will have monthly hCG monitoring for 12 months. If patients do not attain remission and develop persistent GTN as established by FIGO 2000, the tumor will be re-staged and appropriate chemotherapy will be initiated.