Study on Neurocognitive Decline in Patients with Brain Metastases
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT03508752
This clinical trial is exploring the effects of a specific radiation treatment on brain function in patients with multiple brain metastases. The study aims to find the safest dose and evaluate any changes in memory and thinking skills.
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Program Overview
The study is designed to test a radiation treatment for patients with brain metastases, which are cancer cells that have spread to the brain. The first part of the study will determine the safest dose of radiation that can be given. The second part will focus on understanding how this treatment affects patients' memory and thinking abilities over time. Researchers will compare the effects of this treatment to other types of brain radiation treatments to see if it offers any improvements in preserving cognitive function.
Description
Since 2009, over 100 patients with six or more brain metastases have been treated in a single radiosurgery session. Recently, more patients are being treated with radiosurgery, even with a higher number of metastases. This study will first determine the maximum safe dose of radiation (Phase I) by enrolling 7-15 patients at each dose level. Once the safest dose is found, the study will move to Phase II, enrolling 50 patients to evaluate changes in memory and thinking skills over three years. The main goal of Phase I is to assess safety, while Phase II will focus on changes in cognitive function, particularly memory recall. Previous studies have shown varying levels of memory decline with different treatments, and this study aims to find a balance between effective treatment and preserving cognitive abilities.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a performance status score indicating ability to carry out daily activities.
- Have a confirmed diagnosis of a non-blood-related cancer, except for germ cell cancer. Small cell lung cancer is eligible.
- Have six or more brain metastases visible on imaging scans.
- Largest tumor must be 4 cm or smaller.
- No previous radiosurgery to the brain lesions being treated in this study.
- Women and men must agree to use effective birth control during the study and for 90 days after treatment.
- Must be able to understand and sign a consent form agreeing to participate in the study.
Exclusion Criteria
- Have had whole brain radiation therapy before.
- Have leptomeningeal metastasis, which is cancer spread to the lining of the brain and spinal cord.
- Have a life expectancy of less than 4 months.
- Have psychiatric or social issues that would prevent following the study requirements.
- Must not be pregnant or breastfeeding due to potential risks to the baby.
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