Clinical trial · Interventional
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
A Non-Inferiority Prospective Randomized Multicenter Clinical Control Study of Hysteroscopic Repeat Curettage as the Primal Management of Low-risk Postmolar Gestational Trophoblastic Neoplasia
NCT03703271CI-TRIAL-00116461recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study of hysteroscopic repeat curettage as the first-line treatment in low-risk postmolar gestational trophoblastic neoplasia compared with the MTX single drug chemotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gestational Trophoblastic Neoplasia | Gestational Trophoblastic Tumor | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hysteroscopic repeat curettage | Procedure | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- description
- Methotrexate 0.4mg/kg·d, im ,\*5d started at the first day of cycle, two weeks a cycle
- interventionNames
- Drug: Methotrexate
- type
- EXPERIMENTAL
- label
- study group
- description
- hysteroscopic repeat curettage
- interventionNames
- Procedure: hysteroscopic repeat curettage
Primary outcomes (1)
- measure
- The ultimate complete response rate
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.