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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?

Brain Metastases

Study Interventions

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

Study Arms

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

Study Status

Completed

Start Date: April 2014

Completed Date: December 2015

Phase: Phase 2

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02104193

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