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Simvastatin Effect on Radiation Therapy of Brain Metastases

Information source: Ain Shams University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Metastases

Intervention: simvastatin in addition to radiation therapy (Drug); radiation therapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ain Shams University

Official(s) and/or principal investigator(s):
May A Shawki, master, Principal Investigator, Affiliation: Faculty of Pharmacy- Ain Shams university

Overall contact:
Amr S Saad, M.D., Email: docshak76@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: a- Response rate

Secondary outcome:

progression free and overall survival

adverse effects

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Locations and Contacts

Amr S Saad, M.D., Email: docshak76@gmail.com

Ain Shams university Hospitals, Cairo 11566, Egypt; Recruiting
May A Shawki, master, Principal Investigator
Additional Information

Starting date: April 2014
Last updated: July 8, 2015

Page last updated: August 23, 2015

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