Gestational Trophoblastic NeoplasiaPhase 2NCT03703271
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
A Phase 2 study testing Methotrexate and hysteroscopic repeat curettage in people with Gestational Trophoblastic Neoplasia, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 12 to 60 years, women only
- Conditions the study is for
- Gestational Trophoblastic Neoplasia
- What is being tested?
- Methotrexate and hysteroscopic repeat curettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Concurrently participating in other clinical trials
- Unable or unwilling to sign informed consents
- Unable or unwilling to abide by protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Weiguo Lv
Hangzhou, Zhejiang, 310006
Weiguo Lv, Doctor, 13588193832, 13588193832@163.com
About this study
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
Study of hysteroscopic repeat curettage as the first-line treatment in low-risk postmolar gestational trophoblastic neoplasia compared with the MTX single drug chemotherapy
Read the 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 treatment.
- Conditions
- Gestational Trophoblastic Neoplasia
- Being tested
- Methotrexate, hysteroscopic repeat curettage
- Keywords
- postmolar, Gestational Trophoblastic Neoplasia, hysteroscopic, repeat curettage, methotrexate
- Medical subject headings
- Gestational Trophoblastic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Methotrexate chemotherapy
single-agent 5-day methotrexate, two weeks a cycle
hysteroscopic repeat curettageProcedure or surgery
Also called complete curettage
Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Active comparator | Methotrexate 0.4mg/kg·d, im ,*5d started at the first day of cycle, two weeks a cycle Receives: Drug: Methotrexate |
| study group | Experimental | hysteroscopic repeat curettage Receives: Procedure: hysteroscopic repeat curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ultimate complete response rate
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.
Measured: 2 years
Secondary outcomes (7)
chemotherapy-sparing rate
The investigators may calculate the rate of response after the initial treatment of hysteroscopic repeat curettage without chemotherapy
Measured: 2 years
Complications of hysteroscopic repeat curettage surgery
The investigators may record the complications of hysteroscopic repeat curettage surgery
Measured: 2 years
Severity of adverse events as assessed by the WHO
The investigators may record the adverse events of chemotherapy as assessed by the WHO
Measured: 2 years
Overall Survival Rate (OR)
Overall Survival Rate of the two group patients
Measured: 2 years
Ovarian functional evaluation
The investigators may test serum level of anti-mullerian hormone (AMH) every 6 months.
Measured: 2 years
The pregnancy rate
To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail
Measured: 2 years
Menstrual cycle resuming rate
The investigators record the time of menstrual cycle resuming after chemotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Mar 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Trophoblastic NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This protocol amendment transitions the study from a superiority to a non-inferiority design. This 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 an expected cure rate of 98% in both arms, a non-inferiority margin of 10%, a one-sided α of 0.025, 80% power, and 1:1 allocation. With 10% dropout, the final target is 35 patients per arm (70 total). This size is sufficient to test non-inferiority while remaining feasible given current recruitment rates, but it does not provide the confirmatory intent required for a Phase III designation. Therefore, the study is reclassified from Phase III to Phase II (exploratory). The primary endpoint is the ultimate cure rate. Secondary endpoints now include the chemotherapy-sparing rate. All other protocol aspects remain unchanged.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Huazhong University of Science and Technology, Qilu Hospital of Shandong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703271
- Sponsor's protocol ID
- ZJHGTN1212
- Status last verified
- Jun 2026
- First submitted
- 2 Oct 2018
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03703271
- Acronym / sponsor ID
- ZJHGTN1212
- Conditions
- Gestational Trophoblastic Neoplasia
- Keywords
- postmolar, Gestational Trophoblastic Neoplasia, hysteroscopic, repeat curettage, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Huazhong University of Science and Technology, Qilu Hospital of Shandong University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This protocol amendment transitions the study from a superiority to a non-inferiority design. This 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 an expected cure rate of 98% in both arms, a non-inferiority margin of 10%, a one-sided α of 0.025, 80% power, and 1:1 allocation. With 10% dropout, the final target is 35 patients per arm (70 total). This size is sufficient to test non-inferiority while remaining feasible given current recruitment rates, but it does not provide the confirmatory intent required for a Phase III designation. Therefore, the study is reclassified from Phase III to Phase II (exploratory). The primary endpoint is the ultimate cure rate. Secondary endpoints now include the chemotherapy-sparing rate. All other protocol aspects remain unchanged.
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Active comparator | Drug: MethotrexateMethotrexate 0.4mg/kg·d, im ,*5d started at the first day of cycle, two weeks a cycle |
| study group | Experimental | Procedure: hysteroscopic repeat curettagehysteroscopic repeat curettage |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: Methotrexate chemotherapysingle-agent 5-day methotrexate, two weeks a cycle | Drug | chemotherapy |
| hysteroscopic repeat curettageAlso: complete curettageStudy of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia | Procedure or surgery | study group |
Primary outcome
The ultimate complete response rate
Time frame: 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate and hysteroscopic repeat curettage in people with Gestational Trophoblastic Neoplasia, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ultimate complete response rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.