Study on Stereotactic Radiosurgery Before or After Surgery for Cancer Patients with Brain Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03741673

Provider View

This clinical trial is comparing the effectiveness of giving focused radiation treatment, known as stereotactic radiosurgery (SRS), either before or after surgery in patients whose cancer has spread to the brain.

Patient Parameters

Program Overview

The purpose of this study is to determine whether giving stereotactic radiosurgery (SRS) before surgery is more effective than giving it after surgery for patients with brain metastases, which is cancer that has spread to the brain. SRS is a type of radiation therapy that delivers a high dose of radiation to the tumor in a single session, while minimizing exposure to the surrounding healthy brain tissue.

Description

The main goal of this study is to find out if giving SRS before surgery can help prevent the spread of cancer to the brain's protective layers (leptomeningeal disease) better than giving SRS after surgery. Researchers will also look at how well the cancer is controlled in the brain, the rate of new brain metastases, and overall survival between the two approaches.

Additionally, the study will explore how different imaging techniques can help in understanding the tumor and its surrounding environment, and how these treatments affect patients' cognitive functions, quality of life, and their own reported outcomes.

Participants will be randomly assigned to one of two groups:

  • Group I (Pre-Operative SRS): Participants will receive SRS within 15 days of being assigned to this group, followed by surgery within another 15 days. If the cancer returns, additional SRS may be given.

  • Group II (Post-Operative SRS): Participants will undergo surgery within 15 days of being assigned to this group, followed by standard SRS within 30 days. Additional SRS may be given if the cancer returns.

After completing the treatment, participants will have regular follow-up visits to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • The main tumor must be no larger than 4 cm for single-session treatment or 7 cm for multiple-session treatment.
  • Patients must be eligible for SRS within 30 days of surgery, as determined by medical history or a tumor board review.
  • Patients must have a performance status score of 70 or higher on the Karnofsky scale or 2 or lower on the ECOG scale.
  • Patients must agree to be randomly assigned to one of the treatment groups and sign a consent form.
  • No signs of cancer spread to the brain's protective layers on imaging reports.
  • Must have a documented history of cancer.

Exclusion Criteria

  • Patients who have previously received radiation therapy to the brain.
  • Patients with primary tumors of small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
  • Female patients who are pregnant or breastfeeding, due to potential risks from imaging agents used in the study.

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