Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

Gestational Trophoblastic Neoplasia Clinical Trial

— ReCure  

Official title:

Impact of Second Uterine Evacuation in Women With Non-metastatic, Low-risk Gestational Trophoblastic Neoplasia: A Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04756713
• Other study ID #: ReCure
• Status: Recruiting
• Phase: Phase 3
• Start date: February 11, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2022
• Source: Brigham and Women's Hospital
• Contact: MARCIO BARCELLOS, MD
• Phone: (21)2556-9747
• Email: mbezerrab[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasia
• Gestational Trophoblastic Tumor, Non-Metastatic
• Hydatidiform Mole
• Molar Pregnancy
• Neoplasms
• Trophoblastic Neoplasms

Intervention

Procedure:
• Uterine curettage
Manual or electric vacuum aspiration under ultrasound guidance.

Drug:
• Chemotherapy
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.

Locations

Country	Name	City	State
Brazil	Paulista State University UNESP	Botucatu
Brazil	Campinas State University UNICAMP	Campinas
Brazil	University of Caxias do Sul	Caxias Do Sul
Brazil	Federal University of Ceará	Ceará
Brazil	Medical School of Santa Casa da Misericórdia de Porto Alegre	Porto Alegre
Brazil	Maternidade Escola da Universidade Federal do Rio de Janeiro	Rio de Janeiro
Brazil	Federal University of São Paulo UNIFESP	São Paulo

Sponsors (9)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Campinas State University UNICAMP, Federal University of Ceará, Federal University of São Paulo UNIFESP, Maternidade Escola da Universidade Federal do Rio de Janeiro, Medical School of Santa Casa da Misericórdia de Porto Alegr, Paulista State University UNESP BOTUCATU, Universidade Federal do Rio de Janeiro, University of Caxias do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Erratum in: Obstet Gynecol. 2019 Sep;134(3):652. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate from primary therapy	Undetectable hCG on weekly serum assay for at least three weeks	3 years
Secondary	Cycles to remission	Total number of cycles of chemotherapy required to attain remission	3 years
Secondary	Time to remission	Time in days from randomization to remission	3 years
Secondary	Need for multiagent chemotherapy	Need for progression from single agent to multiagent chemotherapy	3 years
Secondary	Relapse	Re-elevation of hCG after achieving remission	1 year
Secondary	Death	Death from any cause	1 year