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 range
12 Years – 60 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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