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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Collaborators: Huazhong University of Science and Technology; Qilu Hospital of Shandong University; Sun Yat-sen University
• Treatments: Methotrexate

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