Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

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Brief Title

Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

Official Title

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

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Remission rate from primary therapy

Secondary Outcome

 Cycles to remission

Condition

Gestational Trophoblastic Neoplasia

Intervention

Uterine curettage

Study Arms / Comparison Groups

 Chemotherapy
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

150

Start Date

February 11, 2021

Completion Date

December 31, 2025

Primary Completion Date

December 31, 2024

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.
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Antonio Braga, MD, PhD, (21)2556-9747, [email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT04756713

Organization ID

ReCure


Responsible Party

Principal Investigator

Study Sponsor

Brigham and Women's Hospital

Collaborators

 Maternidade Escola da Universidade Federal do Rio de Janeiro

Study Sponsor

Antonio Braga, MD, PhD, Study Director, Maternidade Escola da Universidade Federal do Rio de Janeiro


Verification Date

May 2022