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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
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

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
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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
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Arm Title
Uterine evacuation
Arm Type
Experimental
Arm Description
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.
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
No
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
Email
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
Email
mbezerrab@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Antonio Braga, MD
Email
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
No
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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