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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 17, 2016
February 1, 2016
1.6 years
April 1, 2014
February 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
a- Response rate
brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size
4 weeks after radiation therapy
Secondary Outcomes (2)
progression free and overall survival
up to 6 months
adverse effects
during the treatment period
Other Outcomes (3)
quality of life
baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks
cognitive function assessment using Montreal cognitive assessment test
baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks
serum s100 B protein
baseline, after radiation therapy
Study Arms (2)
simvastatin
EXPERIMENTALthey will receive simvastatin in addition to radiation therapy
control
ACTIVE COMPARATORthey will receive radiation therapy only
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients with measurable brain metastases
- Age more than 18 years old
- Patients should be planned for radiation therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams university Hospitals
Cairo, 11566, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
May A Shawki, master
Faculty of Pharmacy- Ain Shams university
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- teaching assisstant
Study Record Dates
First Submitted
April 1, 2014
First Posted
April 4, 2014
Study Start
April 1, 2014
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
February 17, 2016
Record last verified: 2016-02