Simvastatin Effect on Radiation Therapy of Brain Metastases

Phase 2

Completed

• Conditions: Brain Metastases
• Interventions: Drug: simvastatin in addition to radiation therapy; Radiation: radiation therapy

• Registration Number: NCT02104193
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-04
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
simvastatin	simvastatin in addition to radiation therapy	they will receive simvastatin in addition to radiation therapy
control	radiation therapy	they will receive radiation therapy only

Primary Outcome Measures

Name	Time	Method
a- Response rate	4 weeks after radiation therapy	brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size

Secondary Outcome Measures

Name	Time	Method
progression free and overall survival	up to 6 months	it measures time from treatment initiation to either progression or death from any cause
adverse effects	during the treatment period	any adverse/side effect will be evaluated

Trial Locations

Locations (1)

Ain Shams university Hospitals; 🇪🇬 Cairo, Egypt