Study on Avoiding the Hippocampus During Radiation for Treating Cancer Spread to the Brain and Spinal Fluid

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT06518057

This clinical trial is testing a new radiation therapy approach that avoids the hippocampus to treat breast cancer or non-small cell lung cancer that has spread to the brain and spinal fluid. The goal is to reduce side effects while effectively targeting cancer cells.

Patient Parameters

Parameter	Options

Program Overview

This study is exploring a new method of radiation therapy called craniospinal irradiation (CSI) with hippocampal avoidance. It aims to treat patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread to the cerebrospinal fluid and the protective layers around the brain and spinal cord, known as leptomeningeal metastases. Traditional radiation can help relieve symptoms but may not prevent the spread of cancer. CSI targets the brain and spinal cord to kill cancer cells, but it can affect the hippocampus, a part of the brain important for memory. By avoiding the hippocampus, this treatment hopes to reduce neurological side effects while effectively treating the cancer.

Description

Patients in this study will receive a type of radiation therapy called proton or photon VMAT CSI with hippocampal avoidance. This treatment is given once a day, Monday through Friday, for 10 days, each session lasting about 45 minutes. Before starting, patients may have CT or PET/CT scans for screening and additional CT scans for planning the radiation treatment. MRI scans will be done throughout the study to monitor progress. Some patients may also have a lumbar puncture or other methods to collect cerebrospinal fluid.

After finishing the treatment, patients will have follow-up visits at 3, 6, 9, and 12 months, and then if the cancer progresses in the central nervous system, up to one year.

Eligibility Criteria

Inclusion Criteria

Have breast cancer or non-small cell lung cancer that has spread to the brain and spinal fluid, confirmed by scans or fluid tests.
Be eligible for radiation therapy to treat this condition.
Be 18 years or older.
Have a Karnofsky performance status of 60 or higher, indicating the ability to care for oneself with some assistance.
Be able to give informed consent.
Have a hemoglobin level greater than 8 g/dL.
Have an absolute neutrophil count greater than 1,000/mm.
Have a platelet count greater than 100,000/mm.
Women who can become pregnant must have a negative pregnancy test before starting treatment and agree to use effective birth control. Women who cannot become pregnant due to age or surgery do not need a pregnancy test.

Exclusion Criteria

Have multiple serious neurological issues, as assessed by a doctor.
Have widespread cancer with no reasonable treatment options.
Cannot undergo MRI scans with contrast.
Have had previous radiation to the treatment area that would interfere with new treatment.
Have large cancerous areas in the brain's ventricles.
Have brain metastases close to the hippocampus that have not been treated.
Be pregnant or breastfeeding.

Locations

FACILITY	ZIP	CITY	STATE
Fred Hutch/University of Washington Cancer Consortium	98109	Seattle	Washington

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