Simvastatin Effect on Radiation Therapy of Brain Metastases
Information source: Ain Shams University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Metastases
Intervention: simvastatin in addition to radiation therapy (Drug); radiation therapy (Radiation)
Phase: Phase 2
Status: Recruiting
Sponsored by: Ain Shams University Official(s) and/or principal investigator(s): May A Shawki, master, Principal Investigator, Affiliation: Faculty of Pharmacy- Ain Shams university
Overall contact: Amr S Saad, M.D., Email: docshak76@gmail.com
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.
Clinical Details
Official title: The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: a- Response rate
Secondary outcome: progression free and overall survivaladverse effects
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Amr S Saad, M.D., Email: docshak76@gmail.com
Ain Shams university Hospitals, Cairo 11566, Egypt; Recruiting May A Shawki, master, Principal Investigator
Additional Information
Starting date: April 2014
Last updated: July 8, 2015
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