Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestati… (NCT03703271) | Clinical Trial Compass
UnknownPhase 3
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
China214 participantsStarted 2019-03-01
Plain-language 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
Who can participate
Age range12 Years – 60 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
complete remission rate in firstline treatment
Timeframe: 2 years
Trial details
NCT IDNCT03703271
SponsorWomen's Hospital School Of Medicine Zhejiang University