Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

NCT04756713 | Unknown Phase 3 DMC

• 1 other identifier: ReCure
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Remission rate from primary therapy

  Undetectable hCG on weekly serum assay for at least three weeks

  3 years

Secondary Outcomes (5)

• Cycles to remission

  3 years

• Time to remission

  3 years

• Need for multiagent chemotherapy

  3 years

• Relapse

  1 year

• Death

  1 year

Study Arms (2)

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.

Drug: Chemotherapy

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.

Procedure: Uterine curettage

Interventions

Uterine curettage PROCEDURE

Manual or electric vacuum aspiration under ultrasound guidance.

Uterine evacuation

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.

Chemotherapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• High risk GTN (FIGO risk score ≥ 7) or metastatic disease at diagnosis of GTN (stage II, III or IV);
• Histopathological diagnosis of choriocarcinoma, placental site trophoblastic or epithelioid trophoblastic tumor at the second curettage;
• Previous chemotherapy treatment;
• Relapsed GTN;
• Incomplete medical records.
• Loss to follow-up;
• Voluntary desire to stop participating in the study.

Sponsors & Collaborators

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

Study Sites (7)

Paulista State University UNESP

Botucatu, Brazil

NOT YET RECRUITING

Campinas State University UNICAMP

Campinas, Brazil

RECRUITING

University of Caxias do Sul

Caxias do Sul, Brazil

RECRUITING

Federal University of Ceará

Ceará, Brazil

RECRUITING

Medical School of Santa Casa da Misericórdia de Porto Alegre

Porto Alegre, Brazil

RECRUITING

Maternidade Escola da Universidade Federal do Rio de Janeiro

Rio de Janeiro, Brazil

RECRUITING

Federal University of São Paulo UNIFESP

São Paulo, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 27500329 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.

  PMID: 30969220 BACKGROUND

MeSH Terms

Conditions

Gestational Trophoblastic Disease; Hydatidiform Mole

Interventions

Vacuum Curettage; Drug Therapy

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dilatation and Curettage; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Therapeutics

Study Officials

• Antonio Braga, MD, PhD

  Maternidade Escola da Universidade Federal do Rio de Janeiro

  STUDY DIRECTOR

Central Study Contacts

MARCIO BARCELLOS, MD

CONTACT

(21)2556-9747; mbezerrab@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Model Details: Randomized

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: February 11, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (7)