NCT03703271

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

4.8 years

First QC Date

October 2, 2018

Last Update Submit

July 14, 2022

Conditions

Gestational Trophoblastic Neoplasia

Keywords

postmolarGestational Trophoblastic Neoplasiahysteroscopicrepeat curettagemethotrexate

Outcome Measures

Primary Outcomes (1)

  • complete remission rate in firstline treatment

    The investigators may calculate the rate of complete response at the preliminary end point of the trail

    2 years

Secondary Outcomes (6)

  • Complications of hysteroscopic repeat curettage surgery

    2 years

  • Severity of adverse events as assessed by the WHO

    2 years

  • Overall Survival Rate (OR)

    2 years

  • Ovarian functional evaluation

    2 years

  • The pregnancy rate

    2 years

  • +1 more secondary outcomes

Study Arms (2)

chemotherapy

ACTIVE COMPARATOR

Methotrexate 0.4mg/kg·d, im ,\*5d started at the first day of cycle, two weeks a cycle

Drug: Methotrexate

study group

EXPERIMENTAL

hysteroscopic repeat curettage

Procedure: hysteroscopic repeat curettage

Interventions

MethotrexateDRUG

single-agent 5-day methotrexate, two weeks a cycle

Also known as: Methotrexate chemotherapy
chemotherapy
hysteroscopic repeat curettagePROCEDURE

Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia

Also known as: complete curettage
study group

Eligibility Criteria

Age12 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify 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
  • 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.

You may not qualify 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
  • Concurrently participating in other clinical trials
  • Unable or unwilling to sign informed consents
  • Unable or unwilling to abide by protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weiguo Lv

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Trophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsPregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 11, 2018

Study Start

March 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations

CN(1)