Study Comparing Stereotactic Radiosurgery and Observation for Patients with Brain Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT00950001

Provider View

This clinical trial is exploring whether a type of precise radiation therapy called stereotactic radiosurgery is more effective than just monitoring patients after surgery for brain metastases. The goal is to see if this treatment can better control the cancer while minimizing damage to healthy brain tissue.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of stereotactic radiosurgery, a precise form of radiation therapy, with simply observing patients after they have had surgery to remove brain metastases. Researchers want to find out if this treatment can help prevent the cancer from coming back in the same area while causing less harm to normal brain tissue.

Description

The main goal of this study is to see if using stereotactic radiosurgery (SRS) after surgery can help control the cancer in the area where the tumor was removed, reducing the chance of it coming back within six months. Researchers will also look at overall survival rates, the development of new brain metastases, and any side effects from the treatment.

Participants in the study will be randomly assigned to one of two groups:

  • Group 1: Patients will receive stereotactic radiosurgery to the area where the tumor was removed within 30 days after surgery.
  • Group 2: Patients will be closely monitored with regular check-ups after surgery without additional treatment.

After the treatment, patients will have follow-up visits at 5-8 weeks, every 6-9 weeks for the first year, every 3-4 months for the second year, and then every 6 months after that.

Eligibility Criteria

Inclusion Criteria

  • Must be older than 3 years old.
  • Have 3 or fewer new metastatic brain lesions, with at least one completely removed by surgery.
  • The area where the tumor was removed must be 4 cm or smaller in diameter.
  • Any remaining brain metastases must be 3 cm or smaller in diameter.
  • Must be eligible for stereotactic radiosurgery within 30 days after surgery.
  • Must have a performance score of at least 70, indicating good general health.
  • Must be able to have an MRI scan.
  • Must agree to be randomly assigned to one of the treatment groups by signing a consent form.

Exclusion Criteria

  • Have had previous radiation therapy to the brain.
  • Have signs of cancer spreading to the brain's lining (leptomeningeal disease).
  • Have a primary cancer type of small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
  • Women who are pregnant or breastfeeding, due to potential risks from MRI contrast dye.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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