NCT03703271 Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
| NCT ID | NCT03703271 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University |
| Condition | Gestational Trophoblastic Neoplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2019-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 70 participants in total. It began in 2019-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Frequently Asked Questions
Who can join the NCT03703271 clinical trial?
This trial is open to female participants only, aged 12 Years or older, up to 60 Years, studying Gestational Trophoblastic Neoplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03703271 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 70 participants.
Is NCT03703271 currently recruiting?
Yes, NCT03703271 is actively recruiting participants. Visit ClinicalTrials.gov or contact Women's Hospital School Of Medicine Zhejiang University to inquire about joining.
Where is the NCT03703271 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT03703271 clinical trial?
NCT03703271 is sponsored by Women's Hospital School Of Medicine Zhejiang University. The trial plans to enroll 70 participants.