Simvastatin Effect on Radiation Therapy of Brain Metastases

Ain Shams University

Status and phase

Completed

Phase 2

Conditions

Brain Metastases

Treatments

Drug: simvastatin in addition to radiation therapy

Radiation: radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02104193

PH CL 25

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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