Brain Metastases | Simvastatin Effect on Radiation Therapy of Brain Metastases
Brain Metastases research study
What is the primary objective of this 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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug: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
Radiation:radiation therapyradiation therapy 30 Gy delivered in 10 fractions over 2 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
simvastatinthey will receive simvastatin in addition to radiation therapy
controlthey will receive radiation therapy only
Start Date: April 2014
Completed Date: December 2015
Phase: Phase 2
Primary Outcome: a- Response rate
Secondary Outcome: progression free and overall survival
Study sponsors, principal investigator, and references
Principal Investigator: May A Shawki, master
Lead Sponsor: Ain Shams University