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New treatment option for Gestational Trophoblastic Neoplasia
Official title Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
ClinicalTrials.gov ID: NCT03703271
What this study is testing
What is Methotrexate?
Methotrexate is an investigational medicine, being studied as a potential treatment for gestational trophoblastic neoplasia.
Also referred to as Methotrexate chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 60, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 12 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.