Gestational Trophoblastic NeoplasiaPhase 3ReCureNCT04756713
Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia
A Phase 3 study testing Uterine curettage and Chemotherapy in people with Gestational Trophoblastic Neoplasia and Molar Pregnancy, run by Brigham and Women's Hospital at 7 sites in Brazil.
Trial summary
To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Trophoblastic Neoplasia, Molar Pregnancy, Gestational Trophoblastic Tumor, Non-Metastatic
- What is being tested?
- Uterine curettage and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesBrazil
- Study dates
- 11 Feb 2021to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Brazil7 sites, 7 recruiting
- Not yet recruiting
Paulista State University UNESP
Botucatu
Izildinha Maestá
- Recruiting
Campinas State University UNICAMP
Campinas
Daniela A Yela
- Recruiting
University of Caxias do Sul
Caxias do Sul
José Mauro Madi
- Recruiting
Federal University of Ceará
Ceará
Cecília Maria Ponte
- Recruiting
Medical School of Santa Casa da Misericórdia de Porto Alegre
Porto Alegre
Elza -Maria Hartmann
Rodrigo Bernardes Cardoso
- Recruiting
Maternidade Escola da Universidade Federal do Rio de Janeiro
Rio de Janeiro
Marcio Barcellos, MD, mbezerrab@yahoo.com.br
Antonio Braga, MD, bragamed@yahoo.com.br
- Recruiting
Federal University of São Paulo UNIFESP
São Paulo
Sue Yazaki Sun
Marcia Marcelino Ishigai
About this study
Official title: Impact of Second Uterine Evacuation in Women With Non-metastatic, Low-risk Gestational Trophoblastic Neoplasia: A Phase III Trial
To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.
Read the 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
- Being tested
- Uterine curettage, Chemotherapy
- Medical subject headings
- Gestational Trophoblastic Disease, Hydatidiform Mole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine curettageProcedure or surgery
Manual or electric vacuum aspiration under ultrasound guidance.
ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Uterine curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate from primary therapy
Undetectable hCG on weekly serum assay for at least three weeks
Measured: 3 years
Secondary outcomes (5)
Cycles to remission
Total number of cycles of chemotherapy required to attain remission
Measured: 3 years
Time to remission
Time in days from randomization to remission
Measured: 3 years
Need for multiagent chemotherapy
Need for progression from single agent to multiagent chemotherapy
Measured: 3 years
Relapse
Re-elevation of hCG after achieving remission
Measured: 1 year
Death
Death from any cause
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start11 Feb 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational Trophoblastic NeoplasiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- 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, Campinas State University UNICAMP, Paulista State University UNESP BOTUCATU, Medical School of Santa Casa da Misericórdia de Porto Alegr, University of Caxias do Sul
- Responsible party
- Principal investigator, Kevin Elias, Brigham and Women's Hospital
- Investigators
- Antonio Braga, MD, PhD, Study director, Maternidade Escola da Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756713
- Sponsor's protocol ID
- ReCure
- Acronym
- ReCure
- Status last verified
- May 2022
- First submitted
- 12 Feb 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27500329Hemida 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.
PubMed 30969220
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Second Uterine Evacuation in Women With Non-metastatic, Low-risk Gestational Trophoblastic Neoplasia: A Phase III Trial
- ClinicalTrials.gov ID
- NCT04756713
- Acronym / sponsor ID
- ReCure / ReCure
- Conditions
- Gestational Trophoblastic Neoplasia, Molar Pregnancy, Gestational Trophoblastic Tumor, Non-Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- 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, Campinas State University UNICAMP, Paulista State University UNESP BOTUCATU, Medical School of Santa Casa da Misericórdia de Porto Alegr, University of Caxias do Sul
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Drug: ChemotherapyPatients 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. |
| Uterine evacuation | Experimental | Procedure: Uterine curettagePatients 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine curettageManual or electric vacuum aspiration under ultrasound guidance. | Procedure or surgery | Uterine evacuation |
| Chemotherapyconventional 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. | Drug | Chemotherapy |
Primary outcome
Remission rate from primary therapy
Time frame: 3 years
Undetectable hCG on weekly serum assay for at least three weeks
5 secondary outcomes
Cycles to remission
Time frame: 3 years
Time to remission
Time frame: 3 years
Need for multiagent chemotherapy
Time frame: 3 years
Relapse
Time frame: 1 year
Death
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 27500329Osborne 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.
- Background: PubMed 30969220Hemida 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Braga, MD, PhD study director
Maternidade Escola da Universidade Federal do Rio de Janeiro
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Uterine curettage and Chemotherapy in people with Gestational Trophoblastic Neoplasia and Molar Pregnancy, run by Brigham and Women's Hospital at 7 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARCIO BARCELLOS, MD ((21)2556-9747, mbezerrab@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate from primary therapy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.