Gestational Trophoblastic NeoplasmsPhase 2/3SVCGTNNCT02606539
Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms
A Phase 2/3 study testing Total abdominal hysterectomy and methotrexate and Methotrexate plus folinic acid alone in people with Gestational Trophoblastic Neoplasms, run by Maher elesawi kamel elesawi at 2 sites in Egypt.
Trial summary
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Gestational Trophoblastic Neoplasms
- What is being tested?
- Total abdominal hysterectomy and methotrexate and Methotrexate plus folinic acid alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- Sep 2015to Aug 2017
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females
- 40 years or more
- plateau or rising B- hCG titre
- without distant metastasis
- WHO score is less than 7
Who cannot join
- less than 40 years
- distant metastasis to lung and liver
- chronic medical diseases
- WHO score is more than 7
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate
Maher E Kamel elesawi, MSc
- Recruiting
Maher Elesawi Kamel Elesawi
Mīt Ghamr, Eldakahlia
Maher Elesawi, MD student, 01016103662, maherelesawi@yahoo.com
Reda Hemida, MD, 01008622573, redaelshouky@hotmail.com
About this study
Official title: Primary Surgery Plus Single Course Methotrexate Versus Primary Methotrexate for Treatment of Gestational Trophoblastic Neoplasms in Low Risk Cases Above 40y: a Randomized Controled Trial
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy.
Read the detailed description
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy espechialy methotrexate and the investigators try to find a role of surgery plus mehotrexate instead of multiple doses and cycles of chemotherapy that affect the patient quality of life and complication related to both line of management and time of decrease of B-hcg.
- Conditions
- Gestational Trophoblastic Neoplasms
- Being tested
- Total abdominal hysterectomy and methotrexate, Methotrexate plus folinic acid alone
- Keywords
- gestaional trophoblastic neoplasm, hystrectomy, chemotherapy, 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.
Total abdominal hysterectomy and methotrexateProcedure or surgery
Also called surgery and chemotherapy
After written consent laparotomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG (the cycle may be repeated until normalization of B-HCG)
Methotrexate plus folinic acid aloneDrug
Also called chemotharapy
methotrxate 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG and cycle repeated until normalization of B-HCG
| Study group | Role | What they receive |
|---|---|---|
| surgery and methotrxate | Active comparator | The patient will be treated by total abdominal hystrectomy(after written consent laparatomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg alternating with calcium folinate 0.1 mg/kg until normalization of B-HCG Receives: Procedure: Total abdominal hysterectomy and methotrexate |
| methotrxate | Active comparator | The patient will be treated by multiple courses of methotrexate( antifolate) 1mg/kg every 14 days each one alternating in every otherday with calcium folinate 0.1 mg/kg till normalization of B-HCG Receives: Drug: Methotrexate plus folinic acid alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML
Measured: 1-6 months
Secondary outcomes (3)
quality of life( questionairre)
pain scale from zero to 11, return to ordinary activities
Measured: 1-6 months
complications from management
renal, hepatic impairments, anemia,
Measured: 1-6 months
time interval for B-hCG reach less than 5 MU/ML
the time taken for B-hCG to reach below 5 MU/ML
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maher elesawi kamel elesawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maher elesawi kamel elesawi, Mansoura University
- Investigators
- Reda hemida, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606539
- Sponsor's protocol ID
- GTN and surgery
- Acronym
- SVCGTN
- Status last verified
- Nov 2015
- First submitted
- 8 Aug 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Surgery Plus Single Course Methotrexate Versus Primary Methotrexate for Treatment of Gestational Trophoblastic Neoplasms in Low Risk Cases Above 40y: a Randomized Controled Trial
- ClinicalTrials.gov ID
- NCT02606539
- Acronym / sponsor ID
- SVCGTN / GTN and surgery
- Conditions
- Gestational Trophoblastic Neoplasms
- Keywords
- gestaional trophoblastic neoplasm, hystrectomy, chemotherapy, methotrxate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maher elesawi kamel elesawiUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 17 Nov 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.
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy.
Detailed description
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy espechialy methotrexate and the investigators try to find a role of surgery plus mehotrexate instead of multiple doses and cycles of chemotherapy that affect the patient quality of life and complication related to both line of management and time of decrease of B-hcg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery and methotrxate | Active comparator | Procedure: Total abdominal hysterectomy and methotrexateThe patient will be treated by total abdominal hystrectomy(after written consent laparatomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg alternating with calcium folinate 0.1 mg/kg until normalization of B-HCG |
| methotrxate | Active comparator | Drug: Methotrexate plus folinic acid aloneThe patient will be treated by multiple courses of methotrexate( antifolate) 1mg/kg every 14 days each one alternating in every otherday with calcium folinate 0.1 mg/kg till normalization of B-HCG |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- females
- 40 years or more
- plateau or rising B- hCG titre
- without distant metastasis
- WHO score is less than 7
Key exclusion criteria (4 listed)
- less than 40 years
- distant metastasis to lung and liver
- chronic medical diseases
- WHO score is more than 7
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 |
|---|---|---|
| Total abdominal hysterectomy and methotrexateAlso: surgery and chemotherapyAfter written consent laparotomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG (the cycle may be repeated until normalization of B-HCG) | Procedure or surgery | surgery and methotrxate |
| Methotrexate plus folinic acid aloneAlso: chemotharapymethotrxate 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG and cycle repeated until normalization of B-HCG | Drug | methotrxate |
Primary outcome
number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML
Time frame: 1-6 months
3 secondary outcomes
quality of life( questionairre)
Time frame: 1-6 months
complications from management
Time frame: 1-6 months
time interval for B-hCG reach less than 5 MU/ML
Time frame: 1-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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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.
Reda hemida, MD principal investigator
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Total abdominal hysterectomy and methotrexate and Methotrexate plus folinic acid alone in people with Gestational Trophoblastic Neoplasms, run by Maher elesawi kamel elesawi at 2 sites in Egypt.
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 5 inclusion and 4 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 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 maher elesawi, Msc (01016103662, maherelesawi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML (time frame: 1-6 months). 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 22 Mar 2017.