About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
low-risk postmolar gestational trophoblastic neoplasia (GTN)
World Health Organization(WHO) risk score≤4
Age≤60 years; female, Chinese women
Initial treatment
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Methotrexate
Drugsingle-agent 5-day methotrexate, two weeks a cycle
hysteroscopic repeat curettage
Procedure/SurgeryStudy of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
Treatment groups
Trial outcomes
Primary outcomes
The ultimate complete response rate
The investigators may calculate the ultimate complete response rate, defined as the proportion of patients who achieve sustained normalisation of serum hCG without requiring escalation to multi-agent chemotherapy at the predefined trial endpoint.
Secondary outcomes
chemotherapy-sparing rate
The investigators may calculate the rate of response after the initial treatment of hysteroscopic repeat curettage without chemotherapy
Complications of hysteroscopic repeat curettage surgery
The investigators may record the complications of hysteroscopic repeat curettage surgery
Severity of adverse events as assessed by the WHO
The investigators may record the adverse events of chemotherapy as assessed by the WHO
Overall Survival Rate (OR)
Overall Survival Rate of the two group patients
Sponsors and contacts
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Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Sun Yat-sen University
Collaborator
Huazhong University of Science and Technology
Collaborator
Qilu Hospital of Shandong University
Collaborator