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Completed

NCT Number: NCT02104193

Simvastatin Effect on Radiation Therapy of Brain Metastases

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams university Hospitals

Cairo, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin in addition to radiation therapy

Drug

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

radiation therapy

Radiation

radiation therapy 30 Gy delivered in 10 fractions over 2 weeks

Primary outcomes

  1. a- Response rate

    Time frame: 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 outcomes

  1. progression free and overall survival

    Time frame: up to 6 months

    it measures time from treatment initiation to either progression or death from any cause

  2. adverse effects

    Time frame: during the treatment period

    any adverse/side effect will be evaluated

Other outcomes

  1. quality of life

    Time frame: baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks

    measures the patient quality of life

  2. cognitive function assessment using Montreal cognitive assessment test

    Time frame: baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks

    assess the patient cognitive function by the evaluation of Montreal cognitive assessment test score

  3. serum s100 B protein

    Time frame: baseline, after radiation therapy

    evaluate serum s100 B protein at baseline and after 2 weeks

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2014
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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