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Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia

NCT03703271

RecruitingPhase 3

Sponsor: Women's Hospital School Of Medicine Zhejiang University

Conditions: Gestational Trophoblastic Neoplasia

Interventions: Methotrexate, hysteroscopic repeat curettage

Countries: China

Study of hysteroscopic repeat curettage as the first-line treatment in low-risk postmolar gestational trophoblastic neoplasia compared with the MTX single drug chemotherapy

Eligibility overview

Sex: FEMALE

Age: 12 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* low-risk postmolar gestational trophoblastic neoplasia (GTN)
* World Health Organization(WHO) risk score≤4
* Age≤60 years; female, Chinese women
* Initial treatment
* Performance status: Karnofsky score≥60
* Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal,blood urea nitrogen, Cr≤ normal
* Provide written informed consent.

Exclusion Criteria:

* Patients with unconfirmed diagnosis of GTN
* Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
* WHO risk score ≥5分
* The diameter of a single metastatic lesion in the lung was ≥2cm
* The number of lung CT metastases was≥ 5
* With severe or uncontrolled internal disease, unable to receive chemotherapy
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents
* Unable or unwilling to abide by protocol

Locations (1)

Hangzhou, Zhejiang, China