Study Comparing Single and Fractionated Stereotactic Radiosurgery for Treating Brain Metastases

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05222620

Provider View

This clinical trial is exploring whether a single session of focused radiation therapy (SRS) or multiple sessions (FSRS) is more effective in treating brain tumors that have spread from other parts of the body. The study aims to determine which method better controls the tumor and reduces side effects.

Patient Parameters

Program Overview

This study is investigating two different methods of delivering focused radiation therapy to treat brain tumors that have spread from other parts of the body, known as metastatic brain disease. The trial compares single fraction stereotactic radiosurgery (SRS), which involves one session of high-power radiation, with fractionated stereotactic radiosurgery (FSRS), which involves multiple sessions. The goal is to find out which method is more effective in controlling the tumor and minimizing side effects.

Description

The main goal of this study is to find out if fractionated stereotactic radiosurgery (FSRS) leads to fewer treatment failures, such as tumor growth or radiation-related brain damage, compared to single fraction stereotactic radiosurgery (SSRS).

Secondary goals include:

  • Checking if FSRS improves overall survival compared to SSRS.
  • Comparing side effects between the two treatments, including the impact of other therapies like immunotherapy.
  • Evaluating the rates of radiation-related brain damage in both treatment groups.
  • Investigating if there are differences in how the cancer spreads in the brain between the two treatments.
  • Determining if FSRS extends the time before neurological death compared to SSRS.
  • Assessing patient-reported outcomes, such as quality of life, for both treatments.
  • Comparing outcomes based on the type of equipment used for treatment.
  • Analyzing treatment outcomes on a per-tumor basis rather than per patient.

Participants will be randomly assigned to one of two groups:

  • Group A will receive a single session of SRS and undergo MRI scans before and after treatment.
  • Group B will receive multiple sessions of FSRS and also undergo MRI scans before and after treatment.

After completing the treatment, participants will have follow-up visits at 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have brain tumors that have spread from another part of the body, such as the lung, breast, or prostate.
  • At least one brain tumor must be between 2.0 cm and 4.0 cm in size and not previously treated with radiosurgery.
  • Able to undergo an MRI scan with contrast.
  • Women of childbearing potential must have a negative pregnancy test within 7 days before joining the study.
  • Willing and able to provide written consent to participate.
  • Have a Karnofsky performance status of 50 or higher.
  • Have an ECOG performance score of 2 or higher.
  • Previous radiosurgery or surgery is allowed if there is no evidence of tumor growth in those areas.

Exclusion Criteria

  • Have had whole brain radiation before.
  • Have a brain tumor in the brainstem that is 2.0 cm or larger.
  • Have clear evidence of cancer spread to the lining of the brain (leptomeningeal metastasis).
  • Have a brain tumor larger than 4.0 cm.

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