Back to resultsSimvastatin Effect on Radiation Therapy of Brain Metastases
Primary Purpose
Brain Metastases
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
simvastatin in addition to radiation therapy
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastases focused on measuring brain metastases, simvastatin, radiation therapy
Eligibility 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
Sites / Locations
- Ain Shams university Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
simvastatin
control
Arm Description
they will receive simvastatin in addition to radiation therapy
they will receive radiation therapy only
Outcomes
Primary Outcome Measures
a- Response rate
brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size
Secondary Outcome Measures
progression free and overall survival
it measures time from treatment initiation to either progression or death from any cause
adverse effects
any adverse/side effect will be evaluated
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02104193
Brief Title
Simvastatin Effect on Radiation Therapy of Brain Metastases
Official Title
The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
brain metastases, simvastatin, radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
simvastatin
Arm Type
Experimental
Arm Description
they will receive simvastatin in addition to radiation therapy
Arm Title
control
Arm Type
Active Comparator
Arm Description
they will receive radiation therapy only
Intervention Type
Drug
Intervention Name(s)
simvastatin in addition to radiation therapy
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
radiation therapy 30 Gy delivered in 10 fractions over 2 weeks
Primary Outcome Measure Information:
Title
a- Response rate
Description
brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size
Time Frame
4 weeks after radiation therapy
Secondary Outcome Measure Information:
Title
progression free and overall survival
Description
it measures time from treatment initiation to either progression or death from any cause
Time Frame
up to 6 months
Title
adverse effects
Description
any adverse/side effect will be evaluated
Time Frame
during the treatment period
Other Pre-specified Outcome Measures:
Title
quality of life
Description
measures the patient quality of life
Time Frame
baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks
Title
cognitive function assessment using Montreal cognitive assessment test
Description
assess the patient cognitive function by the evaluation of Montreal cognitive assessment test score
Time Frame
baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks
Title
serum s100 B protein
Description
evaluate serum s100 B protein at baseline and after 2 weeks
Time Frame
baseline, after radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May A Shawki, master
Organizational Affiliation
Faculty of Pharmacy- Ain Shams university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams university Hospitals
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Simvastatin Effect on Radiation Therapy of Brain Metastases
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