Study on Photon Craniospinal Irradiation for Treating Cancer Spread to Brain and Spinal Fluid from Breast or Lung Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06910761

Provider View

This clinical trial is exploring a new radiation therapy method called photon craniospinal irradiation (CSI) to treat breast or non-small cell lung cancer that has spread to the brain and spinal fluid. The study aims to see if this treatment can effectively target and reduce cancer in these areas.

Patient Parameters

Program Overview

This study is testing a new radiation therapy called photon craniospinal irradiation (CSI) using a technique known as photon volumetric modulated arc radiotherapy (VMAT). It is designed for 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 disease. The goal is to see if this treatment can effectively target and reduce cancer in these areas.

Description

The main goal of this study is to see how well photon-VMAT-CSI works by measuring how long patients can go without their cancer getting worse in the brain and spinal fluid. Researchers will also look at how many patients respond to the treatment, how long the response lasts, and overall survival rates. They will monitor any side effects and how severe they are, as well as how the treatment affects patients' quality of life, anxiety, and cognitive function.

Patients will receive photon-VMAT-CSI once a day for 10 treatments over 10 to 20 days, Monday through Friday. They will have MRI scans and provide blood and spinal fluid samples throughout the study. After finishing the treatment, patients will have follow-up visits at 1 month and then every 3 months for up to a year.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to understand and sign a consent form.
  • Must have a performance status score of 60 or higher, meaning they can care for themselves but may not be able to work.
  • Must be able to read and understand English or Spanish, or have access to a certified interpreter.
  • Must have a confirmed diagnosis of breast cancer or non-small cell lung cancer.
  • Must have cancer that has spread to the cerebrospinal fluid or meninges, confirmed by scans or tests.
  • Must have certain blood counts and kidney function within normal limits.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for at least 1 month after the last treatment.

Exclusion Criteria

  • Cannot have had chemotherapy, biological therapy, or immunotherapy within 7 days before starting the study treatment.
  • Cannot have had previous radiation that would interfere with the study treatment.
  • Cannot have severe neurological symptoms or uncontrolled disease outside the brain and spinal fluid.
  • Cannot have other serious illnesses or conditions that would make participation unsafe.
  • Cannot have active HIV, hepatitis B, or hepatitis C infections unless they are well-controlled.
  • Cannot have another active cancer that would interfere with the study.
  • Women cannot be pregnant or breastfeeding.
  • Cannot have conditions that would prevent undergoing MRI scans with contrast.
  • Must be able to comply with all study procedures and visits.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia
City of Hope at Irvine Lennar92618IrvineCalifornia

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