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

NCT03703271 | Recruiting Phase 3 DMC

• 1 other identifier: ZJHGTN1212
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Gestational Trophoblastic Neoplasia

Keywords

postmolar; Gestational Trophoblastic Neoplasia; hysteroscopic; repeat curettage; methotrexate

Outcome Measures

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.

  2 years

Secondary Outcomes (7)

• chemotherapy-sparing rate

  2 years

• 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

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

Methotrexate DRUG

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

Also known as: Methotrexate chemotherapy

chemotherapy

hysteroscopic repeat curettage PROCEDURE

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

• Age: 12 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Sun Yat-sen University: collaborator
• Huazhong University of Science and Technology: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Weiguo Lv

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Model Details: This protocol amendment transitions the study from a superiority to a non-inferiority design. The decision, made during an investigator meeting with clinical experts, statisticians, and site representatives, was driven by a marked decline in molar pregnancy/GTN incidence. The sample size was recalculated with expected cure rate 98% in both arms, non-inferiority margin 10%, one-sided α=0.025, power 80%, and 1:1 allocation. A 10% margin allows a clinically acceptable 88% cure rate in the experimental arm, is consistent with prior GTN non-inferiority trials, and avoids the infeasible \>280 patients required for a 5% margin. The calculated sample size is 31 per arm; with 10% dropout, the final target is 35 per arm (70 total). This size is sufficient to test non-inferiority while remaining feasible given current recruitment rates. The primary endpoint refers to the ultimate cure rate. Secondary endpoints now include chemotherapy-sparing rate. All other protocol aspects remain unchanged.

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 11, 2018
• Study Start: March 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CN (1)