Gestational Trophoblastic NeoplasmsPhase 3NCT02639650
Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
A Phase 3 study testing Etoposide, actinomycin D and methotrexate in people with Gestational Trophoblastic Neoplasms, run by Weiguo Lv at 1 site in China.
Trial summary
This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Gestational Trophoblastic Neoplasms
- What is being tested?
- Etoposide, actinomycin D and methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2016to 1 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for high-risk gestational trophoblastic neoplasia (GTN) and stage Ⅳ cases
- World Health Organization(WHO) risk score ≥7, and less than 13
- Age≤60 years; female, Chinese women
- Initial treatment is chemotherapy
- 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 less than 7
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Weiguo Lv
Hangzhou, Zhejiang
Weiguo Lv, Doctor
About this study
Official title: A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.
Read the detailed description
Gestational trophoblastic tumor (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which occur in women of reproductive age. The survival rate of patients with score of 7 or more points, or WHO Ⅳ period for high-risk patients was of 60% to 80%. However, due to severe toxic reactions, long treatment time, loss of optimal reproductive age and increased costs, and treatment failure caused by chemotherapy resistance, high-risk GTN is still one of the tumors seriously affecting the life health and quality of life of young women.
First-line chemotherapy recommended by FIGO is regimen of EMA - CO with corresponding side effects and adverse factors in the following aspects as relatively higer incidence of myelosupression, VP - 16 being associated with a second tumor, especially leukemia, and a definite effect of cyclophosphamide on the failure ovarian function Taxol (Taxol) is the most widely used and most effective broad-spectrum anti-tumor drug in gynecological malignant tumors at present, and T (paclitaxel) +P (platinum drugs) scheme is the first-line chemotherapy scheme in ovarian cancer patients at present. According to references, TP also has effects on resistant and refactory high risk GTN patients.
Given relatively simple operation way of TP chemotherapy, and the effect of chemotherapy in recurrence and high-risk refractory GTN performance,this prospective multicenter randomized controlled clinical research was to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor compared with EMA-CO.
- Conditions
- Gestational Trophoblastic Neoplasms
- Being tested
- Etoposide, actinomycin D, methotrexate, vincristine, cyclophosphamide
- Keywords
- gestational trophoblastic tumor, paclitaxel, cisplatin, carboplatin, chemotherapy
- 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.
EtoposideDrug
Also called VP-16
etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle
actinomycin DDrug
Also called ACTD, Sanamycin
actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle
methotrexateDrug
Also called MTX
methotrexate 100mg/m2, 200mg/m2, ivgtt, tetrahydrofolic acid （FA) 15mg q12h*4(24h after methotrexate injection),started at the first day of cycle, two weeks a cycle
vincristineDrug
Also called VCR
vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle
cyclophosphamideDrug
Also called CTX
cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle
PaclitaxelDrug
Also called Taxol
paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle
CisplatinDrug
Also called DDP
cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle
CarboplatinDrug
Also called CBP
carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle Receives: Drug: Etoposide; Drug: actinomycin D; Drug: methotrexate; Drug: vincristine; Drug: cyclophosphamide |
| study group | Experimental | paclitaxel + cisplatin or carboplatin，two weeks a cycle Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate in firstline treatment
We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.
Measured: 3 years
Secondary outcomes (4)
Severity of adverse events as assessed by the WHO
We calculate the adverse events during and after chemotherapy.
Measured: 3 years
Overall Survival Rate (OR)
We calculate the overall survival rate of high risk GTN patients after chemotherapy.
Measured: 3 years
Ovarian functional evaluation
We may test serum level of anti-mullerian hormone (AMH) every 6 months and the time of menstrual cycle resuming after chemotherapy.
Measured: every 6 months up to 3 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: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study start1 Mar 2016
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 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 NeoplasmsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weiguo Lv
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University, Huazhong University of Science and Technology, First Affiliated Hospital of Zhongshan Medical University
- Responsible party
- Sponsor-investigator, Weiguo Lv, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639650
- Sponsor's protocol ID
- ZJHGTN1211
- Status last verified
- Jun 2022
- First submitted
- 13 Dec 2015
- Last updated
- 3 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
- ClinicalTrials.gov ID
- NCT02639650
- Acronym / sponsor ID
- ZJHGTN1211
- Conditions
- Gestational Trophoblastic Neoplasms
- Keywords
- gestational trophoblastic tumor, paclitaxel, cisplatin, carboplatin, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Weiguo LvUniversity, hospital or other
- Collaborators
- Shandong University, Huazhong University of Science and Technology, First Affiliated Hospital of Zhongshan Medical University
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 24 Dec 2015 (estimated)
- 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.
This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.
Detailed description
Gestational trophoblastic tumor (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which occur in women of reproductive age. The survival rate of patients with score of 7 or more points, or WHO Ⅳ period for high-risk patients was of 60% to 80%. However, due to severe toxic reactions, long treatment time, loss of optimal reproductive age and increased costs, and treatment failure caused by chemotherapy resistance, high-risk GTN is still one of the tumors seriously affecting the life health and quality of life of young women.
First-line chemotherapy recommended by FIGO is regimen of EMA - CO with corresponding side effects and adverse factors in the following aspects as relatively higer incidence of myelosupression, VP - 16 being associated with a second tumor, especially leukemia, and a definite effect of cyclophosphamide on the failure ovarian function Taxol (Taxol) is the most widely used and most effective broad-spectrum anti-tumor drug in gynecological malignant tumors at present, and T (paclitaxel) +P (platinum drugs) scheme is the first-line chemotherapy scheme in ovarian cancer patients at present. According to references, TP also has effects on resistant and refactory high risk GTN patients.
Given relatively simple operation way of TP chemotherapy, and the effect of chemotherapy in recurrence and high-risk refractory GTN performance,this prospective multicenter randomized controlled clinical research was to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor compared with EMA-CO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Etoposide, Drug: actinomycin D, Drug: methotrexate, Drug: vincristine, Drug: cyclophosphamideetoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle |
| study group | Experimental | Drug: Paclitaxel, Drug: Cisplatin, Drug: Carboplatinpaclitaxel + cisplatin or carboplatin，two weeks a cycle |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients who International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for high-risk gestational trophoblastic neoplasia (GTN) and stage Ⅳ cases
- World Health Organization(WHO) risk score ≥7, and less than 13
- Age≤60 years; female, Chinese women
- Initial treatment is chemotherapy
- Performance status: Karnofsky score≥60
Key exclusion criteria (7 listed)
- Patients with unconfirmed diagnosis of GTN
- Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
- WHO risk score less than 7
- With severe or uncontrolled internal disease, unable to receive chemotherapy
- Concurrently participating in other clinical trials
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 |
|---|---|---|
| EtoposideAlso: VP-16etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle | Drug | control group |
| actinomycin DAlso: ACTD, Sanamycinactinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle | Drug | control group |
| methotrexateAlso: MTXmethotrexate 100mg/m2, 200mg/m2, ivgtt, tetrahydrofolic acid （FA) 15mg q12h*4(24h after methotrexate injection),started at the first day of cycle, two weeks a cycle | Drug | control group |
| vincristineAlso: VCRvincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle | Drug | control group |
| cyclophosphamideAlso: CTXcyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle | Drug | control group |
| PaclitaxelAlso: Taxolpaclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle | Drug | study group |
| CisplatinAlso: DDPcisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle | Drug | study group |
| CarboplatinAlso: CBPcarboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin | Drug | study group |
Primary outcome
complete remission rate in firstline treatment
Time frame: 3 years
We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.
4 secondary outcomes
Severity of adverse events as assessed by the WHO
Time frame: 3 years
Overall Survival Rate (OR)
Time frame: 3 years
Ovarian functional evaluation
Time frame: every 6 months up to 3 years
The pregnancy rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoposide, actinomycin D and methotrexate in people with Gestational Trophoblastic Neoplasms, run by Weiguo Lv 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 7 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: status not confirmed, as of the sponsor's last update on 3 Jun 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Weiguo, Doctor (86-13588819218, lbwg@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate in firstline treatment (time frame: 3 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 3 Jun 2022.