Gestational Trophoblastic Neoplasia
Conditions
Keywords
postmolar, Gestational Trophoblastic Neoplasia, hysteroscopic, repeat curettage, methotrexate
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 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
DRUGMethotrexate
single-agent 5-day methotrexate, two weeks a cycle
PROCEDUREhysteroscopic repeat curettage
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Sun Yat-sen University
Huazhong University of Science and Technology
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This protocol amendment transitions the study from a superiority to a non-inferiority design. The decision, made during an investigator meeting with clinical experts, statisticians, and site representatives, was driven by a marked decline in molar pregnancy/GTN incidence. The sample size was recalculated with expected cure rate 98% in both arms, non-inferiority margin 10%, one-sided α=0.025, power 80%, and 1:1 allocation. A 10% margin allows a clinically acceptable 88% cure rate in the experimental arm, is consistent with prior GTN non-inferiority trials, and avoids the infeasible \>280 patients required for a 5% margin. The calculated sample size is 31 per arm; with 10% dropout, the final target is 35 per arm (70 total). This size is sufficient to test non-inferiority while remaining feasible given current recruitment rates. The primary endpoint refers to the ultimate cure rate. Secondary endpoints now include chemotherapy-sparing rate. All other protocol aspects remain unchanged.
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ultimate complete response rate | 2 years | The investigators may calculate the ultimate complete response rate, defined as the proportion of patients who achieve sustained normalisation of serum hCG without requiring escalation to multi-agent chemotherapy at the predefined trial endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| chemotherapy-sparing rate | 2 years | The investigators may calculate the rate of response after the initial treatment of hysteroscopic repeat curettage without chemotherapy |
| Complications of hysteroscopic repeat curettage surgery | 2 years | The investigators may record the complications of hysteroscopic repeat curettage surgery |
| Severity of adverse events as assessed by the WHO | 2 years | The investigators may record the adverse events of chemotherapy as assessed by the WHO |
| Overall Survival Rate (OR) | 2 years | Overall Survival Rate of the two group patients |
| Ovarian functional evaluation | 2 years | The investigators may test serum level of anti-mullerian hormone (AMH) every 6 months. |
| The pregnancy rate | 2 years | To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail |
| Menstrual cycle resuming rate | 2 years | The investigators record the time of menstrual cycle resuming after chemotherapy |
Countries
China
Outcome results
None listed