Brain MetastasesPhase 2NCT02104193
Simvastatin Effect on Radiation Therapy of Brain Metastases
A Phase 2 study testing simvastatin in addition to radiation therapy and radiation therapy in people with Brain Metastases, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- simvastatin in addition to radiation therapy and radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Dec 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with measurable brain metastases
- Age more than 18 years old
- Patients should be planned for radiation therapy
Who cannot join
- Renal dysfunction (more than 1 upper normal level)
- Hepatic dysfunction (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3 times the upper normal level )
- Pregnancy or lactation.
- Known hypersensitivity to simvastatin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study
The purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases.
Read the detailed description
Despite current advances in therapies, the outcome for patients with brain metastases is fatal. New therapeutic approaches, such as radiosensitizing agents, are needed to provide a significant survival advantage for those patients. Statins have been reported to enhance the efficacy of radiotherapy in addition to a neuroprotective effect. The aim of the study is to evaluate the effect of simvastatin on the efficacy and safety of radiation therapy in patients with brain metastases and on improving patients' quality of life.
- Conditions
- Brain Metastases
- Being tested
- simvastatin in addition to radiation therapy, radiation therapy
- Keywords
- brain metastases, simvastatin, radiation therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatin in addition to radiation therapyDrug
simvastatin 80 mg tablet once daily during the radiation therapy period in addition to radiation therapy 30 Gy delivered in 10 fractions over 2 weeks
radiation therapyRadiation
radiation therapy 30 Gy delivered in 10 fractions over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| simvastatin | Experimental | they will receive simvastatin in addition to radiation therapy Receives: Drug: simvastatin in addition to radiation therapy |
| control | Active comparator | they will receive radiation therapy only Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
a- Response rate
brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size
Measured: 4 weeks after radiation therapy
Secondary outcomes (2)
progression free and overall survival
it measures time from treatment initiation to either progression or death from any cause
Measured: up to 6 months
adverse effects
any adverse/side effect will be evaluated
Measured: during the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAy Ahmed Shawki, Ain Shams University
- Investigators
- May A Shawki, master, Principal investigator, Faculty of Pharmacy- Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104193
- Sponsor's protocol ID
- PH CL 25
- Status last verified
- Feb 2016
- First submitted
- 1 Apr 2014
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study
- ClinicalTrials.gov ID
- NCT02104193
- Acronym / sponsor ID
- PH CL 25
- Conditions
- Brain Metastases
- Keywords
- brain metastases, simvastatin, radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Apr 2014 (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.
The purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases.
Detailed description
Despite current advances in therapies, the outcome for patients with brain metastases is fatal. New therapeutic approaches, such as radiosensitizing agents, are needed to provide a significant survival advantage for those patients. Statins have been reported to enhance the efficacy of radiotherapy in addition to a neuroprotective effect. The aim of the study is to evaluate the effect of simvastatin on the efficacy and safety of radiation therapy in patients with brain metastases and on improving patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simvastatin | Experimental | Drug: simvastatin in addition to radiation therapythey will receive simvastatin in addition to radiation therapy |
| control | Active comparator | Radiation: radiation therapythey will receive radiation therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with measurable brain metastases
- Age more than 18 years old
- Patients should be planned for radiation therapy
Key exclusion criteria (4 listed)
- Renal dysfunction (more than 1 upper normal level)
- Hepatic dysfunction (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3 times the upper normal level )
- Pregnancy or lactation.
- Known hypersensitivity to simvastatin
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 |
|---|---|---|
| simvastatin in addition to radiation therapysimvastatin 80 mg tablet once daily during the radiation therapy period in addition to radiation therapy 30 Gy delivered in 10 fractions over 2 weeks | Drug | simvastatin |
| radiation therapyradiation therapy 30 Gy delivered in 10 fractions over 2 weeks | Radiation | control |
Primary outcome
a- Response rate
Time frame: 4 weeks after radiation therapy
brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size
2 secondary outcomes
progression free and overall survival
Time frame: up to 6 months
adverse effects
Time frame: during the treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
May A Shawki, master principal investigator
Faculty of Pharmacy- Ain Shams university
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 simvastatin in addition to radiation therapy and radiation therapy in people with Brain Metastases, run by Ain Shams University at 1 site 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 3 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: finished, as of the sponsor's last update on 17 Feb 2016. 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 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a- Response rate (time frame: 4 weeks after radiation therapy). 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 17 Feb 2016.