Study on Improving Brain Function with Whole Brain Radiation Therapy Using a New Technique

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05045950

Provider View

This clinical trial is testing a new method of whole brain radiation therapy to see if it can help maintain brain function in patients with brain tumors. The study will use a special technique called pulsed reduced dose rate (PRDR) to deliver the treatment.

Patient Parameters

Program Overview

The purpose of this study is to test a new way of giving whole brain radiation therapy to patients with brain tumors. The treatment uses a technique called pulsed reduced dose rate (PRDR) to deliver radiation in a way that might better protect brain function. Patients will receive this treatment within two weeks of joining the study, with a total dose of 30 Gy given in 10 sessions. The study will also look at how this new method affects brain function compared to traditional treatments.

Description

This study is designed to test the safety and effectiveness of a new radiation therapy technique called pulsed reduced dose rate (PRDR) for treating brain tumors that have spread from other parts of the body. The study will involve 53 adult patients who will receive this treatment to see if it can help maintain brain function better than standard whole brain radiation therapy. Patients will start the treatment within two weeks of joining the study and will receive a total dose of 30 Gy in 10 sessions. They will also take a medication called memantine to help protect brain function, starting two days before the treatment begins. The study will collect information on how well patients tolerate the treatment and its effects on their brain function. Patients must have a confirmed diagnosis of brain tumors from a solid cancer and meet other health criteria to participate.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good overall health status with a performance score of less than 2.
  • Have a confirmed diagnosis of a solid tumor cancer that has spread to the brain.
  • Can have had previous treatments for brain tumors, such as surgery or radiosurgery, if completed at least 7 to 14 days before joining the study.
  • Have a life expectancy of more than six months from other cancer areas.
  • Have measurable brain tumors.
  • Have a creatinine clearance of 30 mL/min or higher.
  • Must start the PRDR treatment within two weeks of joining the study.
  • Be able to complete cognitive function tests in English.
  • Have controlled other cancers that do not affect overall health or life expectancy.
  • Be willing to give consent and follow the treatment and follow-up schedule.

Exclusion Criteria

  • Have brain tumors from blood cancers or central nervous system cancers.
  • Have cancer being treated with the goal of cure.
  • Have cancer spread to the brain's lining (leptomeningeal metastases).
  • Cannot have MRI scans with contrast.
  • Cannot take memantine or similar medications.
  • Have severe kidney disease (stage IV-V) or end-stage kidney disease.
  • Have brain tumors larger than 5 cm that have not been removed.
  • Have had previous whole brain radiation therapy.
  • Have a history of dementia not related to brain tumors.
  • Be pregnant or unwilling to use contraception during the study.
  • Have serious medical or psychiatric conditions that prevent understanding or completing the study.
  • Non-native English speakers are excluded due to potential language-related issues in cognitive testing.

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