Study Comparing Proton and Photon Radiation Therapy for Cancer Spread to Brain and Spine Fluid

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04343573

This clinical trial is exploring whether proton craniospinal radiation therapy or partial photon radiation therapy is more effective in treating cancer that has spread to the fluid around the brain and spine. The study also aims to compare the side effects of these treatments.

Patient Parameters

Program Overview

The purpose of this study is to determine which type of radiation therapy is better at preventing cancer that has spread to the fluid around the brain and spine from getting worse. Proton craniospinal radiation therapy targets the entire area containing the brain and spinal fluid, while partial photon radiation therapy focuses only on areas with symptoms, like the whole brain or part of the spine. Researchers also want to see if proton therapy can help improve symptoms caused by this type of cancer spread. The study will also compare the side effects of both treatments. Patients receiving proton therapy will be treated at the New York Proton Center or, if not possible, at ProCure in New Jersey.

Eligibility Criteria

Inclusion Criteria

  • Have a solid tumor cancer that has spread to the fluid around the brain and spine, confirmed by scans or tests.
  • Be eligible for radiation therapy to treat this condition.
  • Open to patients of all ages.
  • For those 16 and older, a performance status score of 60 or higher; for those under 16, a Lansky score of 60 or higher.
  • Adults or their legal representatives must be able to give informed consent; for children, a parent must provide consent.
  • Have adequate bone marrow function:
    • Hemoglobin level above 8g/dL
    • Neutrophil count above 1,000/mm
    • Platelet count above 100,000/mm
  • Women must either not be able to have children or have a negative pregnancy test before starting treatment.
  • Those who can have children must agree to use effective birth control.

Exclusion Criteria

  • Have multiple serious neurological issues, as assessed by a doctor.
  • Have widespread disease without treatment options.
  • Cannot undergo MRI scans with contrast.
  • Have had previous radiation to the treatment area that limits new treatment options.
  • Are pregnant or breastfeeding.

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