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

NCT ID: NCT03703271

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-12-31

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

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

Conditions

Gestational Trophoblastic Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy

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

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

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

study group

hysteroscopic repeat curettage

Group Type: EXPERIMENTAL

hysteroscopic repeat curettage

Intervention Type: PROCEDURE

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

Interventions

Methotrexate

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

Intervention Type: DRUG

hysteroscopic repeat curettage

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

Intervention Type: PROCEDURE

Other Intervention Names

Methotrexate chemotherapy; complete curettage

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Weiguo Lv

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Weiguo Lv, Doctor

Role: primary

13588193832@163.com

13588193832

Other Identifiers

ZJHGTN1212

Identifier Type: -

Identifier Source: org_study_id