NCT02104193

Simvastatin Effect on Radiation Therapy of Brain Metastases

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
DRUG	simvastatin in addition to radiation therapy	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
RADIATION	radiation therapy	radiation therapy 30 Gy delivered in 10 fractions over 2 weeks

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2014-04-04
• Last updated: 2016-02-17

Locations

1 site across 1 country: Egypt