Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
Primary Purpose
Gestational Trophoblastic Neoplasia
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Methotrexate
hysteroscopic repeat curettage
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Trophoblastic Neoplasia focused on measuring postmolar, Gestational Trophoblastic Neoplasia, hysteroscopic, repeat curettage, methotrexate
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
Sites / Locations
- Weiguo LvRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
chemotherapy
study group
Arm Description
Methotrexate 0.4mg/kg·d, im ,*5d started at the first day of cycle, two weeks a cycle
hysteroscopic repeat curettage
Outcomes
Primary Outcome Measures
complete remission rate in firstline treatment
The investigators may calculate the rate of complete response at the preliminary end point of the trail
Secondary Outcome Measures
Complications of hysteroscopic repeat curettage surgery
The investigators may record the complications of hysteroscopic repeat curettage surgery
Severity of adverse events as assessed by the WHO
The investigators may record the adverse events of chemotherapy as assessed by the WHO
Overall Survival Rate (OR)
Overall Survival Rate of the two group patients
Ovarian functional evaluation
The investigators may test serum level of anti-mullerian hormone (AMH) every 6 months.
The pregnancy rate
To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail
Menstrual cycle resuming rate
The investigators record the time of menstrual cycle resuming after chemotherapy
Full Information
NCT ID
NCT03703271
First Posted
October 2, 2018
Last Updated
July 14, 2022
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Sun Yat-sen University, Huazhong University of Science and Technology, Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT03703271
Brief Title
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
Official Title
A Prospective Randomized Multicenter Clinical Control Study of Hysteroscopic Repeat Curettage as the Primal Management of Low-risk Postmolar Gestational Trophoblastic Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Sun Yat-sen University, Huazhong University of Science and Technology, Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Trophoblastic Neoplasia
Keywords
postmolar, Gestational Trophoblastic Neoplasia, hysteroscopic, repeat curettage, methotrexate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
Methotrexate 0.4mg/kg·d, im ,*5d started at the first day of cycle, two weeks a cycle
Arm Title
study group
Arm Type
Experimental
Arm Description
hysteroscopic repeat curettage
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Methotrexate chemotherapy
Intervention Description
single-agent 5-day methotrexate, two weeks a cycle
Intervention Type
Procedure
Intervention Name(s)
hysteroscopic repeat curettage
Other Intervention Name(s)
complete curettage
Intervention Description
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
Primary Outcome Measure Information:
Title
complete remission rate in firstline treatment
Description
The investigators may calculate the rate of complete response at the preliminary end point of the trail
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Complications of hysteroscopic repeat curettage surgery
Description
The investigators may record the complications of hysteroscopic repeat curettage surgery
Time Frame
2 years
Title
Severity of adverse events as assessed by the WHO
Description
The investigators may record the adverse events of chemotherapy as assessed by the WHO
Time Frame
2 years
Title
Overall Survival Rate (OR)
Description
Overall Survival Rate of the two group patients
Time Frame
2 years
Title
Ovarian functional evaluation
Description
The investigators may test serum level of anti-mullerian hormone (AMH) every 6 months.
Time Frame
2 years
Title
The pregnancy rate
Description
To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail
Time Frame
2 years
Title
Menstrual cycle resuming rate
Description
The investigators record the time of menstrual cycle resuming after chemotherapy
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Weiguo Lv
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiguo Lv, Doctor
Phone
13588193832
Email
13588193832@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
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