Simvastatin Effect on Radiation Therapy of Brain Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study

Conditions
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Brain Metastases

Intervention / Treatment
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* Drug: simvastatin in addition to radiation therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with measurable brain metastases Age more than 18 years old Patients should be planned for radiation therapy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simvastatin<br>they will receive simvastatin in addition to radiation therapy | Drug: simvastatin in addition to radiation therapy<br>* 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<br>|
| Active Comparator: control<br>they will receive radiation therapy only | Radiation: radiation therapy<br>* radiation therapy 30 Gy delivered in 10 fractions over 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a- Response rate | brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size | 4 weeks after radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free and overall survival | it measures time from treatment initiation to either progression or death from any cause | up to 6 months | 
| adverse effects | any adverse/side effect will be evaluated | during the treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain metastases, simvastatin, radiation therapy