Study on Combining Local and Systemic Treatments for Brain Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06649058

Provider View

This clinical trial is exploring whether adding targeted radiation therapy to standard treatments can help control brain metastases in patients whose cancer has spread to the brain. The study aims to determine if this approach can improve outcomes for patients with low-risk brain metastases.

Patient Parameters

Program Overview

The purpose of this study is to find out if using a focused type of radiation therapy, called stereotactic radiosurgery (SRS), can help control brain metastases in patients who have already received systemic therapy (treatment that affects the whole body). Researchers want to see if treating all brain metastases that don't respond to systemic therapy, rather than just those that are getting worse, can better manage the disease.

Description

This study is divided into several parts:

Primary Objectives:

  • To see if adding focused radiation therapy (cSRS) can help patients with brain metastases live longer without the disease getting worse, after they have received initial systemic therapy.
  • To compare the effects of treating all brain metastases that don't fully respond to systemic therapy with SRS, versus only treating those that are worsening.

Secondary Objectives:

  • To report how well brain metastases respond to systemic therapy based on different treatment regimens and cancer types.
  • To track any neurological side effects that occur with different radiation therapy options.
  • To evaluate the rates of a condition called leptomeningeal disease (LMD) in patients and how different radiation therapies affect these rates.
  • To assess changes in brain function and cognition with different treatment options.
  • To analyze overall survival rates and how they differ with various radiation therapy options.

Exploratory Objectives:

  • To explore how imaging tests can predict outcomes for brain metastases treated with systemic therapy.
  • To compare different methods of measuring tumor response.
  • To investigate the use of machine learning to predict treatment outcomes.
  • To study the relationship between blood markers and treatment strategies.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Evaluated by a team of specialists, including an oncologist, radiation oncologist, and neurosurgeon.
  • Expected to live more than 6 months.
  • The treatment plan should be agreed upon by the medical team and expected to benefit the brain.
  • Brain metastases should not need immediate local treatment like surgery or radiation.
  • Brain metastases should be suitable for SRS as initial treatment.
  • Must have signed a consent form agreeing to participate.
  • Have confirmed metastatic cancer with at least one measurable brain metastasis (5 mm or larger).
  • Have at least one measurable brain lesion that hasn't been treated with SRS before.
  • Previous SRS or surgery is allowed if other untreated lesions remain.
  • Must not have neurological symptoms from brain metastases or need minimal steroids.
  • Have a good performance status (ECOG 0 or 1).
  • The treatment plan should be agreed upon by the patient's primary oncologist.
  • Non-English speakers can participate with translation support.

Exclusion Criteria

  • History of cancer spreading to the brain's lining (leptomeningeal involvement).
  • Certain types of cancer like small cell lung cancer, lymphoma, or leukemia.
  • Non-small cell lung cancer with specific mutations and planned targeted therapy.
  • Previous whole-brain radiation therapy (WBRT).
  • Any brain metastasis larger than 3 cm.
  • Previous progression on the planned systemic therapy.
  • Recent use of the planned systemic therapy.
  • Previous severe side effects from the planned systemic therapy.
  • Major medical, neurological, or psychiatric conditions that prevent full participation.
  • History of another cancer unless treated and cancer-free for 2 years.
  • Weight over 450 pounds.
  • Previous SRS too close to a current brain metastasis.
  • Inability to have an MRI or MRI contrast.
  • Brain metastases with significant bleeding.

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