Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methotrexate, hysteroscopic repeat curettage.
- Who it may be relevant to
- Registry conditions: Gestational Trophoblastic Neoplasia. Basic parameters: 12 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Non-Inferiority Prospective Randomized Multicenter Clinical Control Study of Hysteroscopic Repeat Curettage as the Primal Management of Low-risk Postmolar Gestational Trophoblastic Neoplasia
Overview
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 non-Inferiority 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
Interventions
- 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
Primary outcome measures
- The ultimate complete response rate [Time frame: 2 years]
Secondary outcome measures (7)
- chemotherapy-sparing rate [Time frame: 2 years]
- Complications of hysteroscopic repeat curettage surgery [Time frame: 2 years]
- Severity of adverse events as assessed by the WHO [Time frame: 2 years]
- Overall Survival Rate (OR) [Time frame: 2 years]
- Ovarian functional evaluation [Time frame: 2 years]
- The pregnancy rate [Time frame: 2 years]
- Menstrual cycle resuming rate [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Weiguo Lv — Hangzhou
Identifiers
NCT: NCT03703271 · ZJHGTN1212