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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age12-60
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

low-risk postmolar gestational trophoblastic neoplasia (GTN)

World Health Organization(WHO) risk score≤4

Age≤60 years; female, Chinese women

Initial treatment

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Methotrexate

    Drug

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

  • hysteroscopic repeat curettage

    Procedure/Surgery

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: chemotherapyActive comparator 1 intervention
Group B: study groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The ultimate complete response rate

The investigators may calculate the ultimate complete response rate, defined as the proportion of patients who achieve sustained normalisation of serum hCG without requiring escalation to multi-agent chemotherapy at the predefined trial endpoint.

Time frame
2 years

Secondary outcomes

1

chemotherapy-sparing rate

The investigators may calculate the rate of response after the initial treatment of hysteroscopic repeat curettage without chemotherapy

Time frame
2 years
2

Complications of hysteroscopic repeat curettage surgery

The investigators may record the complications of hysteroscopic repeat curettage surgery

Time frame
2 years
3

Severity of adverse events as assessed by the WHO

The investigators may record the adverse events of chemotherapy as assessed by the WHO

Time frame
2 years
4

Overall Survival Rate (OR)

Overall Survival Rate of the two group patients

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women's Hospital School Of Medicine Zhejiang University

Lead sponsor

Sun Yat-sen University

Collaborator

Huazhong University of Science and Technology

Collaborator

Qilu Hospital of Shandong University

Collaborator