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Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia (ReCure)

Primary Purpose

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

Status

Recruiting

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Uterine curettage

Chemotherapy

About this trial

This is an interventional treatment trial for Gestational Trophoblastic Neoplasia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

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;
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);
Relapsed GTN;
Incomplete medical records.
Loss to follow-up;
Voluntary desire to stop participating in the study.

Sites / Locations

Paulista State University UNESP
Campinas State University UNICAMPRecruiting
University of Caxias do SulRecruiting
Federal University of CearáRecruiting
Medical School of Santa Casa da Misericórdia de Porto AlegreRecruiting
Maternidade Escola da Universidade Federal do Rio de JaneiroRecruiting
Federal University of São Paulo UNIFESPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy

Uterine evacuation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Remission rate from primary therapy

Undetectable hCG on weekly serum assay for at least three weeks

Secondary Outcome Measures

Cycles to remission

Total number of cycles of chemotherapy required to attain remission

Time to remission

Time in days from randomization to remission

Need for multiagent chemotherapy

Need for progression from single agent to multiagent chemotherapy

Relapse

Re-elevation of hCG after achieving remission

Death

Death from any cause

Full Information

NCT ID

NCT04756713

First Posted

February 12, 2021

Last Updated

May 23, 2022

Sponsor

Brigham and Women's Hospital

Collaborators

Maternidade Escola da Universidade Federal do Rio de Janeiro, Universidade Federal do Rio de Janeiro, Federal University of Ceará, Federal University of São Paulo UNIFESP, Campinas State University UNICAMP, Paulista State University UNESP BOTUCATU, Medical School of Santa Casa da Misericórdia de Porto Alegr, University of Caxias do Sul

1. Study Identification

Unique Protocol Identification Number

NCT04756713

Brief Title

Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

Acronym

ReCure

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomized

Masking

InvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

Arm Title

Uterine evacuation

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Uterine curettage

Intervention Description

Manual or electric vacuum aspiration under ultrasound guidance.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Remission rate from primary therapy

Description

Undetectable hCG on weekly serum assay for at least three weeks

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Cycles to remission

Description

Total number of cycles of chemotherapy required to attain remission

Time Frame

3 years

Title

Time to remission

Description

Time in days from randomization to remission

Time Frame

3 years

Title

Need for multiagent chemotherapy

Description

Need for progression from single agent to multiagent chemotherapy

Time Frame

3 years

Title

Relapse

Description

Re-elevation of hCG after achieving remission

Time Frame

1 year

Title

Death

Description

Death from any cause

Time Frame

1 year

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

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: 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; 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); Relapsed GTN; Incomplete medical records. Loss to follow-up; Voluntary desire to stop participating in the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MARCIO BARCELLOS, MD

Phone

(21)2556-9747

mbezerrab@yahoo.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Braga, MD, PhD

Organizational Affiliation

Maternidade Escola da Universidade Federal do Rio de Janeiro

Official's Role

Study Director

Facility Information:

Facility Name

Paulista State University UNESP

City

Botucatu

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Izildinha Maestá

Facility Name

Campinas State University UNICAMP

City

Campinas

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniela A Yela

Facility Name

University of Caxias do Sul

City

Caxias Do Sul

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Mauro Madi

Facility Name

Federal University of Ceará

City

Ceará

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cecília Maria Ponte

Facility Name

Medical School of Santa Casa da Misericórdia de Porto Alegre

City

Porto Alegre

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elza -Maria Hartmann

First Name & Middle Initial & Last Name & Degree

Rodrigo Bernardes Cardoso

Facility Name

Maternidade Escola da Universidade Federal do Rio de Janeiro

City

Rio de Janeiro

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcio Barcellos, MD

mbezerrab@yahoo.com.br

First Name & Middle Initial & Last Name & Degree

Antonio Braga, MD

bragamed@yahoo.com.br

Facility Name

Federal University of São Paulo UNIFESP

City

São Paulo

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sue Yazaki Sun

First Name & Middle Initial & Last Name & Degree

Marcia Marcelino Ishigai

First Name & Middle Initial & Last Name & Degree

Gustavo Rubino Focchi

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27500329

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.

Results Reference

background

PubMed Identifier

30969220

Citation

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.

Results Reference

background

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Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

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