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

A Prospective Randomized Multicenter Clinical Control Study of Hysteroscopic Repeat Curettage as the Primal Management of Low-risk Postmolar Gestational Trophoblastic Neoplasia

Study of hysteroscopic repeat curettage as the first-line treatment in low-risk postmolar gestational trophoblastic neoplasia compared with the MTX single drug chemotherapy

Study Overview

• Status: Recruiting
• Conditions: Gestational Trophoblastic Neoplasia
• Intervention / Treatment: Drug: Methotrexate; Procedure: hysteroscopic repeat curettage

Detailed Description

Gestational trophoblastic neoplasia (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which are secondary to hydatidiform mole, and 95% of GTN patients present low-risk gestational trophoblastic neoplasia(LR-GTN).In the 1960s and 1970s, with the in-depth study of the disease, it was found that the malignant tumor was highly sensitive to chemotherapy and had ideal tumor marker HCG to guide the treatment and follow-up. Therefore, GTN was the best malignant tumor with the overall cure rate of LR-GTN nearly 100%.MTX single-drug multi-course chemotherapy is the classic treatment of LR-GTN recommended by FIGO, but most patients can develop gastrointestinal, blood and liver toxicity during chemotherapy. In addition, the longer treatment cycle also brings a lot of discomfort to patients.

In recent years, some scholars proposed that the selection of treatment regimen of LR-GTN secondary to hydatidiform pregnancy should consider the toxic and side effects of chemotherapy, the maintenance of patients' physiological functions and quality of life.Retrospective studies abroad have shown that LR-GTN delayed chemotherapy for hydatidiform mole pregnancy only started chemotherapy for LR-GTN at a certain stage of progression, and the results did not change the prognosis of LR-GTN but reduced the rate of chemotherapy.In addition, for some patients with ultra-low risk of LR-GTN in hydatidiform pregnancy undergoing hysteroscopic repeat curettage , the rate of chemotherapy can be reduced, the related costs can be reduced and the quality of life of patients can be improved.

In this prospective, multicenter, randomized, controlled clinical study, with the routine use of a gleam of MTX single drug treatment scheme for comparison, comparing uterine cavity again emptying delay chemotherapy guided by parallel hysteroscopy surgery clinical curative effect and adverse reaction, which discuss after hydatidiform mole ultra-low dangerous GTN patients with uterine cavity emptying again guided by hysteroscopy surgery as a line of ultra low dangerous GTN patients after hydatidiform mole security and feasibility of the treatmen

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Weiguo Lv
      • Contact: Weiguo Lv, Doctor; Phone Number: 13588193832; Email: 13588193832@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: chemotherapy; Methotrexate 0.4mg/kg·d, im ,*5d started at the first day of cycle, two weeks a cycle	Drug: Methotrexate; single-agent 5-day methotrexate, two weeks a cycle; Other Names: Methotrexate chemotherapy
Experimental: study group; hysteroscopic repeat curettage	Procedure: hysteroscopic repeat curettage; Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia; Other Names: complete curettage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of hysteroscopic repeat curettage surgery	The investigators may record the complications of hysteroscopic repeat curettage surgery	2 years
Severity of adverse events as assessed by the WHO	The investigators may record the adverse events of chemotherapy as assessed by the WHO	2 years
Overall Survival Rate (OR)	Overall Survival Rate of the two group patients	2 years
Ovarian functional evaluation	The investigators may test serum level of anti-mullerian hormone (AMH) every 6 months.	2 years
The pregnancy rate	To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail	2 years
Menstrual cycle resuming rate	The investigators record the time of menstrual cycle resuming after chemotherapy	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: methotrexate; postmolar; Gestational Trophoblastic Neoplasia; hysteroscopic; repeat curettage
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal; Pregnancy Complications; Pregnancy Complications, Neoplastic; Trophoblastic Neoplasms; Neoplasms; Gestational Trophoblastic Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: ZJHGTN1212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No