Study on Same-Day Radiation Planning and Treatment for Brain Metastases with Reduced Margins

Sponsor: Ayal A. Aizer, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07132190

Provider View

This clinical trial is testing a new approach to radiation therapy for brain metastases, where radiation planning and treatment happen on the same day. The goal is to ensure the entire tumor is targeted by the high-dose radiation, potentially improving treatment outcomes.

Patient Parameters

Program Overview

The study aims to see if planning and delivering radiation treatment on the same day can effectively target brain metastases. By shortening the time between planning and treatment, the study hopes to keep the tumor fully within the radiation area. Participants will be randomly assigned to receive brain-directed stereotactic radiation with either a 1mm or 0mm margin. If more than 2-3 days pass since the last scan, new planning scans will be done during treatment.

Description

This study explores a new method of delivering radiation therapy for brain metastases, where the treatment plan is adjusted in real-time based on the patient's current condition. This approach, called adaptively designed radiation, uses same-day MRI scans to plan and deliver treatment, aiming to reduce the time between planning and treatment. The study will test if this method can better control brain metastases and reduce the risk of radiation side effects. Participants will have a preliminary treatment plan based on an initial MRI scan. This plan will be checked for quality and safety over 1-2 weeks. On the treatment day, a new MRI will be done to update the plan, and the treatment will be given. The main goal is to see how many patients have tumors that extend beyond the standard planning margin at treatment time. The study will also look at how often the cancer returns or causes side effects when using same-day planning and treatment with different margin sizes.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed solid cancer with at least one brain tumor that is either growing, remaining, or returning, and meets one of these conditions:
    • Growing at least 1.0mm per week based on recent MRI scans
    • Close to a swollen area in the brain (within 1.0cm)
    • Near a surgical site created within 30 days (within 5.0cm)
    • Close to another area causing physical changes (within 5.0cm)
  • Be at least 18 years old
  • Have a Karnofsky performance status of 60 or higher, indicating the ability to care for oneself with some help
  • Expected to live at least 3-6 months, as judged by the doctor
  • Able to understand and willing to sign a consent form, either on paper or electronically

Exclusion Criteria

  • Cannot undergo a brain MRI
  • Cannot receive gadolinium, a contrast agent used in MRIs
  • Have end-stage kidney disease
  • Have widespread leptomeningeal disease, a type of cancer spread in the brain
  • Pregnant or breastfeeding women, due to potential risks to the baby

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