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

Gestational Trophoblastic Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03703271
• Other study ID #: ZJHGTN1212
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 60 Years

Eligibility

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?

• 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

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasia
• Neoplasms

Intervention

Drug:
• Methotrexate
single-agent 5-day methotrexate, two weeks a cycle

Procedure:
• hysteroscopic repeat curettage
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia

Locations

Country	Name	City	State
China	Weiguo Lv	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Huazhong University of Science and Technology, Qilu Hospital of Shandong University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications of hysteroscopic repeat curettage surgery	The investigators may record the complications of hysteroscopic repeat curettage surgery	2 years
Secondary	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
Secondary	Overall Survival Rate (OR)	Overall Survival Rate of the two group patients	2 years
Secondary	Ovarian functional evaluation	The investigators may test serum level of anti-mullerian hormone (AMH) every 6 months.	2 years
Secondary	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
Secondary	Menstrual cycle resuming rate	The investigators record the time of menstrual cycle resuming after chemotherapy	2 years