Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

NCT ID: NCT04756713

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2025-12-31

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.

Conditions

Gestational Trophoblastic Neoplasia; Molar Pregnancy; Gestational Trophoblastic Tumor, Non-Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chemotherapy

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.

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: 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.

Uterine evacuation

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.

Group Type: EXPERIMENTAL

Uterine curettage

Intervention Type: PROCEDURE

Manual or electric vacuum aspiration under ultrasound guidance.

Interventions

Uterine curettage

Manual or electric vacuum aspiration under ultrasound guidance.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maternidade Escola da Universidade Federal do Rio de Janeiro

UNKNOWN

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: collaborator

Federal University of Ceará

UNKNOWN

Sponsor Role: collaborator

Federal University of São Paulo UNIFESP

UNKNOWN

Sponsor Role: collaborator

Campinas State University UNICAMP

UNKNOWN

Sponsor Role: collaborator

Paulista State University UNESP BOTUCATU

UNKNOWN

Sponsor Role: collaborator

Medical School of Santa Casa da Misericórdia de Porto Alegr

UNKNOWN

Sponsor Role: collaborator

University of Caxias do Sul

UNKNOWN

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kevin Elias

Co-investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Braga, MD, PhD

Role: STUDY_DIRECTOR

Maternidade Escola da Universidade Federal do Rio de Janeiro

Locations

Paulista State University UNESP

Botucatu, , Brazil

Site Status: NOT_YET_RECRUITING

Campinas State University UNICAMP

Campinas, , Brazil

Site Status: RECRUITING

University of Caxias do Sul

Caxias do Sul, , Brazil

Site Status: RECRUITING

Federal University of Ceará

Ceará, , Brazil

Site Status: RECRUITING

Medical School of Santa Casa da Misericórdia de Porto Alegre

Porto Alegre, , Brazil

Site Status: RECRUITING

Maternidade Escola da Universidade Federal do Rio de Janeiro

Rio de Janeiro, , Brazil

Site Status: RECRUITING

Federal University of São Paulo UNIFESP

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

MARCIO BARCELLOS, MD

Role: CONTACT

mbezerrab@yahoo.com.br

(21)2556-9747

Facility Contacts

Izildinha Maestá

Role: primary

Daniela A Yela

Role: primary

José Mauro Madi

Role: primary

Cecília Maria Ponte

Role: primary

Elza -Maria Hartmann

Role: primary

Marcio Barcellos, MD

Role: primary

mbezerrab@yahoo.com.br

Antonio Braga, MD

Role: backup

bragamed@yahoo.com.br

Sue Yazaki Sun

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 27500329 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30969220 (View on PubMed)

Other Identifiers

ReCure

Identifier Type: -

Identifier Source: org_study_id