Study on Radiation Treatment Options for Large Brain Metastases (BIGSHOT)

Sponsor: Medical University of South Carolina

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07227610

Provider View

This clinical trial is comparing two types of radiation treatments for patients with large brain tumors (2-5 cm). The study aims to find out which method is more effective and safer for treating these tumors.

Patient Parameters

Program Overview

The purpose of this study is to compare two radiation treatments for large brain tumors (2-5 cm): staged stereotactic radiosurgery (SSRS) and fractionated stereotactic radiotherapy (FSRT). Both treatments are standard options for patients with large brain metastases. The study will evaluate how well each treatment works, their safety, and how the tumors respond.

Description

Brain metastases are tumors that have spread to the brain from other parts of the body. They are becoming more common as cancer treatments improve and patients live longer. Traditionally, these brain tumors were treated with whole brain radiation therapy (WBRT), but newer methods like stereotactic radiosurgery (SRS) are now preferred because they target only the tumors and have fewer side effects.

For small brain tumors (less than 2 cm), SRS works very well. However, for larger tumors, it is more challenging to control them with radiation alone. This study is looking at two ways to treat larger brain tumors with radiation:

  1. Fractionated SRS (FSRT): This involves giving the radiation in 3-5 separate treatments, allowing normal brain tissue to recover between sessions.
  2. Staged SRS (SSRS): This involves two treatment sessions spaced 3-6 weeks apart. The first session uses a lower dose to minimize side effects, and the second session can use a higher dose if the tumor responds well.

The study will compare these two methods to see which one provides better control of the tumors with fewer side effects. Both methods are already used in practice, but this study will provide more information on which is better for large brain tumors.

Eligibility Criteria

Inclusion Criteria

  • Must be able and willing to provide informed consent before joining the study.
  • Must be willing to follow all study procedures and be available for the entire study duration.
  • Must be 18 years or older.
  • Must have a Karnofsky Performance Status (KPS) score of 60 or higher, indicating they can care for themselves with some assistance.
  • Must have a brain tumor measuring between 2 cm and 5 cm in size, confirmed by a scan.
    • Can have multiple tumors, but only up to two large ones (2-5 cm) can be treated in the study.
    • Additional smaller tumors (less than 2 cm) can be treated with single-session SRS.
    • Tumors must be at least 5mm away from the optic nerves.
  • Must have a history of invasive cancer outside the brain within the last 3 years.
  • Must be able to medically tolerate SRS.
  • Must be neurologically stable, meaning immediate surgery is not needed.
  • Must have a negative pregnancy test if of childbearing potential.
  • Must agree to use contraception during the study to prevent pregnancy.

Exclusion Criteria

  • Have had previous radiation treatment to the brain in the area of the large tumor being studied.
  • Have leptomeningeal disease (LMD), which is cancer spread to the lining of the brain and spinal cord.
  • Cannot undergo an MRI with contrast.
  • Plan to receive chemotherapy or immunotherapy within 3 days before, on the day of, or 3 days after the radiation treatment.

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