Gestational Trophoblastic Neoplasia, Gestational Trophoblastic Tumor, Non-Metastatic, Molar Pregnancy
Conditions
Brief 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.
Interventions
PROCEDUREUterine curettage
Manual or electric vacuum aspiration under ultrasound guidance.
DRUGChemotherapy
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
Maternidade Escola da Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
Federal University of Ceará
Federal University of São Paulo UNIFESP
Campinas State University UNICAMP
Paulista State University UNESP BOTUCATU
Medical School of Santa Casa da Misericórdia de Porto Alegr
University of Caxias do Sul
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Treatment assignments are made by a remote investigator not involved in the clinical care of the patient using a coded key with random block sizes.
Intervention model description
Randomized
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission rate from primary therapy | 3 years | Undetectable hCG on weekly serum assay for at least three weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cycles to remission | 3 years | Total number of cycles of chemotherapy required to attain remission |
| Time to remission | 3 years | Time in days from randomization to remission |
| Need for multiagent chemotherapy | 3 years | Need for progression from single agent to multiagent chemotherapy |
| Relapse | 1 year | Re-elevation of hCG after achieving remission |
| Death | 1 year | Death from any cause |
Countries
Brazil
Contacts
Primary ContactMARCIO BARCELLOS, MD
Outcome results
None listed