Clinical trial NCT04756713: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gestational Trophoblastic Neoplasia
Molar Pregnancy
Gestational Trophoblastic Tumor, Non-Metastatic
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Maternidade Escola da Universidade Federal do Rio de Janeiro
name: Universidade Federal do Rio de Janeiro
name: Federal University of Ceará
name: Federal University of São Paulo UNIFESP
name: Campinas State University UNICAMP
name: Paulista State University UNESP BOTUCATU
name: Medical School of Santa Casa da Misericórdia de Porto Alegr
name: University of Caxias do Sul
First posted: 2021-02-16
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Remission rate from primary therapy
timeFrame: 3 years
Secondary outcomes:
measure: Cycles to remission
timeFrame: 3 years
measure: Time to remission
timeFrame: 3 years
measure: Need for multiagent chemotherapy
timeFrame: 3 years
measure: Relapse
timeFrame: 1 year
measure: Death
timeFrame: 1 year
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Paulista State University UNESP
city: Campinas
country: Brazil
facility: Campinas State University UNICAMP
city: Caxias Do Sul
country: Brazil
facility: University of Caxias do Sul
city: Ceará
country: Brazil
facility: Federal University of Ceará
city: Porto Alegre
country: Brazil
facility: Medical School of Santa Casa da Misericórdia de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Maternidade Escola da Universidade Federal do Rio de Janeiro
city: São Paulo
country: Brazil
facility: Federal University of São Paulo UNIFESP
Study officials:
affiliation: Maternidade Escola da Universidade Federal do Rio de Janeiro
name: Antonio Braga, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.