To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Manual or electric vacuum aspiration under ultrasound guidance.
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.
Paulista State University UNESP
Botucatu, Brazil
NOT_YET_RECRUITINGCampinas State University UNICAMP
Campinas, Brazil
RECRUITINGUniversity of Caxias do Sul
Caxias do Sul, Brazil
Remission rate from primary therapy
Undetectable hCG on weekly serum assay for at least three weeks
Time frame: 3 years
Cycles to remission
Total number of cycles of chemotherapy required to attain remission
Time frame: 3 years
Time to remission
Time in days from randomization to remission
Time frame: 3 years
Need for multiagent chemotherapy
Need for progression from single agent to multiagent chemotherapy
Time frame: 3 years
Relapse
Re-elevation of hCG after achieving remission
Time frame: 1 year
Death
Death from any cause
Time frame: 1 year
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Federal University of Ceará
Ceará, Brazil
RECRUITINGMedical School of Santa Casa da Misericórdia de Porto Alegre
Porto Alegre, Brazil
RECRUITINGMaternidade Escola da Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil
RECRUITINGFederal University of São Paulo UNIFESP
São Paulo, Brazil
RECRUITING