Simvastatin Effect on Radiation Therapy of Brain Metastases
Conditions
Brain Metastases
Conditions: official terms
Brain Neoplasms - Neoplasm Metastasis
Conditions: Keywords
brain metastases, simvastatin, radiation therapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: simvastatin in addition to radiation therapy Type: Drug
Name: radiation therapy Type: Radiation
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: 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
Location
Ain Shams university Hospitals
Cairo, Egypt
Status: Recruiting
Start Date
April 2014
Sponsors
Ain Shams University
Source
Ain Shams University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page