Hysteroscopic Repeat Curettage as First-Line Treatment for Low-Risk Postmolar GTN
Official title: A Non-Inferiority Prospective Randomized Multicenter Clinical Control Study of Hysteroscopic Repeat Curettage as the Primal Management of Low-risk Postmolar Gestational Trophoblastic Neoplasia
Run by Women's Hospital School Of Medicine Zhejiang University · NCT03703271 · Data updated 2026-11-12
This study tests whether hysteroscopic repeat curettage can be a first-line option for low-risk postmolar GTN, compared with methotrexate chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 60 Years |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | March 1, 2019 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT03703271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with low-risk postmolar GTN (WHO score ≤4), up to 60 years old, eligible for either hysteroscopic treatment or methotrexate, and willing to provide informed consent.
✕Probably not a fit
Patients with higher GTN risk scores (≥5), larger pulmonary metastases, or contraindications to surgery or methotrexate may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial investigates a surgical approach—hysteroscopic repeat curettage—as the initial treatment for low-risk postmolar gestational trophoblastic neoplasia and compares it to standard methotrexate single-drug chemotherapy. Participants are women up to 60 years old with WHO risk scores ≤4 and confirmed LR-GTN following hydatidiform mole. The study aims to balance disease control with quality of life by potentially reducing chemotherapy-related toxicity while maintaining high cure rates. Interventions include methotrexate and hysteroscopic repeat curettage, with eligibility requiring adequate organ function and informed consent. The lead sponsor is Women’s Hospital School of Medicine Zhejiang University, with collaboration from multiple Chinese institutions and a defined geographic site in Hangzhou.
Why it matters
Potential benefit: If successful, patients may avoid or reduce chemotherapy-related side effects while maintaining high cure rates.
How similar studies have gone: Previous retrospective studies suggested reduced chemotherapy exposure without compromising prognosis, but prospective randomized data in this exact comparison are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Weiguo Lv
Hangzhou, Zhejiang, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.