Gestational Trophoblastic DiseasePhase 2/3NCT03280979
Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia
A Phase 2/3 study testing rescue regimen and high dose methotrxate in people with Gestational Trophoblastic Disease, run by Assiut University.
Trial summary
Gestational trophoblastic neoplasia (GTN) are malignant lesions that arise from abnormal proliferation of placental trophoblast. The pathologic conditions that make up this entity include invasive partial and complete hydatidiform mole, choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Trophoblastic Disease
- What is being tested?
- rescue regimen and high dose methotrxate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Oct 2019
- Phase
- Phase 2/3
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-50
- BW: 50-100 kg
- willing and consenting to be enrolled in the study
- Absence of active vaginal bleeding which requires surgical intervention • - WHO score <6
Who cannot join
- Renal and liver dysfunction or blood dyscariasis
- high risk persistent gestational trophoblastic disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Rescue Regimen and High Dose Methotrexate in the Managment of Presistent Gestational Trophoplastic Neoplasia :( A Randomized Controlled Trial )
Gestational trophoblastic neoplasia (GTN) are malignant lesions that arise from abnormal proliferation of placental trophoblast. The pathologic conditions that make up this entity include invasive partial and complete hydatidiform mole, choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT). GTN often arises after molar pregnancies but can also occur after any gestation including miscarriages and term pregnancies. In the United States, hydatidiform moles are observed in approximately 1/600 therapeutic abortions and 1/1000-2000 pregnancies . Most cases of GTN are diagnosed when the serum hCG levels plateau or rise in patients being observed after the diagnosis of hydatidiform mole.These malignancies are highly susceptible to chemotherapy and it is often possible to achieve cure while preserving the woman's reproductive function
Read the detailed description
When reporting GTN data, it is useful to use both the FIGO anatomic staging system and prognostic scoring system . A FIGO score of 6 or less indicates low-risk GTN whereas a score of 7 or more identifies high-risk disease.
Table 1- FIGO Anatomical staging of gestational trophoblastic neoplasia:
Stage I Disease confined to the uterus Stage II Disease extends to the outside of the uterus, but is limited to the genital structures Stage III Disease extends to the lungs, with or without genital tract involvement Stage IV All other metastatic sites
Table 2- FIGO Scoring system:
FIGO SCORING 0 1 2 4 Age (years) Antecedent pregnancy Interval months from end of index pregnancy to treatment Pretreatment serum hCG (iu/l) Largest tumour size, including uterus Site of metastases Number of metastases Previous failed chemotherapy <40 ≥40 - - mole abortion term <4 4-6 7-12 >12 <1000 1000-10000 10000-100000 >100000 <3cm 3-4cm ≥5 - Lung spleen\&kidney GIT liver\&brain
- 1-4 5-8 >8
- - 1 drug 2 or more drugs
RCOG guidelines (No. 38February 2010 ) recommends the use of rescue regimen of alternating methotrexate( MTX) and leucoverin for 8 days (class D). However, several protocols using MTX were described. No prospective randomised controlled trials have been done to compare the efficacy of resue regimen with the ther protocols. In a retrospective study done showed that high dose methotrexate regimen is more effective than the rescue regimen.
In addition, several concerns have been raised towards the use of leucoverin with methotrexate, although reducing the side effects, however, it may increase the resistence to the effect of MTX .
On the other hand, High dose regimen offers a less hospital stay which may be more convenient to the patients, together with the same incidence of side effects.
In our study we are going to compare the efficacy and tolerance of both regimens in patients diagnosed to have low risk PGTN.
- Conditions
- Gestational Trophoblastic Disease
- Being tested
- rescue regimen, high dose methotrxate
- 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.
rescue regimenDrug
In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of TX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days.
high dose methotrxateDrug
In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid
| Study group | Role | What they receive |
|---|---|---|
| study group1 | Experimental | In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of MTX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days. Receives: Drug: rescue regimen |
| study group2 | Experimental | In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid Receives: Drug: high dose methotrxate |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
cure rate till B hcG is negative and then 2 consolidation regimens
Measured: 12 month
Secondary outcomes (1)
decline in Bhcg
Number of cycles for decline in BhCG
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study startOct 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Trophoblastic DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahraa Magdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280979
- Sponsor's protocol ID
- RR&HDMPGTN
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Rescue Regimen and High Dose Methotrexate in the Managment of Presistent Gestational Trophoplastic Neoplasia :( A Randomized Controlled Trial )
- ClinicalTrials.gov ID
- NCT03280979
- Acronym / sponsor ID
- RR&HDMPGTN
- Conditions
- Gestational Trophoblastic Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 13 Sep 2017 (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.
Gestational trophoblastic neoplasia (GTN) are malignant lesions that arise from abnormal proliferation of placental trophoblast. The pathologic conditions that make up this entity include invasive partial and complete hydatidiform mole, choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT). GTN often arises after molar pregnancies but can also occur after any gestation including miscarriages and term pregnancies. In the United States, hydatidiform moles are observed in approximately 1/600 therapeutic abortions and 1/1000-2000 pregnancies . Most cases of GTN are diagnosed when the serum hCG levels plateau or rise in patients being observed after the diagnosis of hydatidiform mole.These malignancies are highly susceptible to chemotherapy and it is often possible to achieve cure while preserving the woman's reproductive function
Detailed description
When reporting GTN data, it is useful to use both the FIGO anatomic staging system and prognostic scoring system . A FIGO score of 6 or less indicates low-risk GTN whereas a score of 7 or more identifies high-risk disease.
Table 1- FIGO Anatomical staging of gestational trophoblastic neoplasia:
Stage I Disease confined to the uterus Stage II Disease extends to the outside of the uterus, but is limited to the genital structures Stage III Disease extends to the lungs, with or without genital tract involvement Stage IV All other metastatic sites
Table 2- FIGO Scoring system:
FIGO SCORING 0 1 2 4 Age (years) Antecedent pregnancy Interval months from end of index pregnancy to treatment Pretreatment serum hCG (iu/l) Largest tumour size, including uterus Site of metastases Number of metastases Previous failed chemotherapy <40 ≥40 - - mole abortion term <4 4-6 7-12 >12 <1000 1000-10000 10000-100000 >100000 <3cm 3-4cm ≥5 - Lung spleen\&kidney GIT liver\&brain
- 1-4 5-8 >8
- - 1 drug 2 or more drugs
RCOG guidelines (No. 38February 2010 ) recommends the use of rescue regimen of alternating methotrexate( MTX) and leucoverin for 8 days (class D). However, several protocols using MTX were described. No prospective randomised controlled trials have been done to compare the efficacy of resue regimen with the ther protocols. In a retrospective study done showed that high dose methotrexate regimen is more effective than the rescue regimen.
In addition, several concerns have been raised towards the use of leucoverin with methotrexate, although reducing the side effects, however, it may increase the resistence to the effect of MTX .
On the other hand, High dose regimen offers a less hospital stay which may be more convenient to the patients, together with the same incidence of side effects.
In our study we are going to compare the efficacy and tolerance of both regimens in patients diagnosed to have low risk PGTN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group1 | Experimental | Drug: rescue regimenIn the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of MTX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days. |
| study group2 | Experimental | Drug: high dose methotrxateIn the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-50
- BW: 50-100 kg
- willing and consenting to be enrolled in the study
- Absence of active vaginal bleeding which requires surgical intervention • - WHO score <6
Key exclusion criteria (2 listed)
- Renal and liver dysfunction or blood dyscariasis
- high risk persistent gestational trophoblastic disease.
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 |
|---|---|---|
| rescue regimenIn the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of TX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days. | Drug | study group1 |
| high dose methotrxateIn the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid | Drug | study group2 |
Primary outcome
cure rate
Time frame: 12 month
cure rate till B hcG is negative and then 2 consolidation regimens
1 secondary outcome
decline in Bhcg
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rescue regimen and high dose methotrxate in people with Gestational Trophoblastic Disease, run by Assiut University.
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 4 inclusion and 2 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 zahraa magdy, md (01002603379, zahraamagdy92@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: 12 month). 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 13 Sep 2017.