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

Women's Hospital School Of Medicine Zhejiang University

Status and phase

Enrolling

Phase 3

Conditions

Gestational Trophoblastic Neoplasia

Treatments

Procedure: hysteroscopic repeat curettage

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT03703271

ZJHGTN1212

Details and patient eligibility

About

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

Full 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

Enrollment

214 estimated patients

Sex

Female

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

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