A Phase 3 interventional study of Uterine curettage and Chemotherapy in Gestational Trophoblastic Neoplasia, Molar Pregnancy and Gestational Trophoblastic Tumor, Non-Metastatic, sponsored by Brigham and Women's Hospital. Recruiting at 7 sites in Brazil. Open to female participants. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Brigham and Women's Hospital · Phase 3, Interventional, and Treatment
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.
57 studies on the registry are indexed under Gestational Trophoblastic Disease; 16 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 35 interventional studies indexed under Gestational Trophoblastic Disease.
Browse Gestational Trophoblastic Disease studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Chemotherapy
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.
Procedure: Uterine curettage
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.
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
Plan to share: No
Started Feb 2021 (actual). Primary completion is estimated for Dec 2024, 46 months after the start.
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