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| Name | Class |
|---|---|
| Maternidade Escola da Universidade Federal do Rio de Janeiro | UNKNOWN |
| Universidade Federal do Rio de Janeiro | OTHER |
| Federal University of Ceará | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Active Comparator | 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. |
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| Uterine evacuation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterine curettage | Procedure | Manual or electric vacuum aspiration under ultrasound guidance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Remission rate from primary therapy | Undetectable hCG on weekly serum assay for at least three weeks | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cycles to remission | Total number of cycles of chemotherapy required to attain remission | 3 years |
| Time to remission | Time in days from randomization to remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MARCIO BARCELLOS, MD | Contact | (21)2556-9747 | mbezerrab@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Braga, MD, PhD | Maternidade Escola da Universidade Federal do Rio de Janeiro | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paulista State University UNESP | Not yet recruiting | Botucatu | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27500329 | Background | Osborne RJ, Filiaci VL, Schink JC, Mannel RS, Behbakht K, Hoffman JS, Spirtos NM, Chan JK, Tidy JA, Miller DS. Second Curettage for Low-Risk Nonmetastatic Gestational Trophoblastic Neoplasia. Obstet Gynecol. 2016 Sep;128(3):535-542. doi: 10.1097/AOG.0000000000001554. | |
| 30969220 | Background | Hemida R, Vos EL, El-Deek B, Arafa M, Toson E, Burger CW, van Doorn HC. Second Uterine Curettage and the Number of Chemotherapy Courses in Postmolar Gestational Trophoblastic Neoplasia: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):1024-1031. doi: 10.1097/AOG.0000000000003232. |
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| ID | Term |
|---|---|
| D031901 | Gestational Trophoblastic Disease |
| D006828 | Hydatidiform Mole |
| ID | Term |
|---|---|
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014619 | Vacuum Curettage |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D004107 | Dilatation and Curettage |
| D003475 | Curettage |
| D013514 | Surgical Procedures, Operative |
| D013509 | Gynecologic Surgical Procedures |
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| Federal University of São Paulo |
| OTHER |
| Campinas State University UNICAMP | UNKNOWN |
| Paulista State University UNESP BOTUCATU | UNKNOWN |
| Medical School of Santa Casa da Misericórdia de Porto Alegr | UNKNOWN |
| University of Caxias do Sul | UNKNOWN |
Randomized
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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.
| Chemotherapy | Drug | 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. |
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| 3 years |
| Need for multiagent chemotherapy | Need for progression from single agent to multiagent chemotherapy | 3 years |
| Relapse | Re-elevation of hCG after achieving remission | 1 year |
| Death | Death from any cause | 1 year |
| Campinas State University UNICAMP | Recruiting | Campinas | Brazil |
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| University of Caxias do Sul | Recruiting | Caxias do Sul | Brazil |
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| Federal University of Ceará | Recruiting | Ceará | Brazil |
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| Medical School of Santa Casa da Misericórdia de Porto Alegre | Recruiting | Porto Alegre | Brazil |
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| Maternidade Escola da Universidade Federal do Rio de Janeiro | Recruiting | Rio de Janeiro | Brazil |
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| Federal University of São Paulo UNIFESP | Recruiting | São Paulo | Brazil |
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| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D013519 | Urogenital Surgical Procedures |
| D013812 | Therapeutics |