Comparing Radiation Treatment Before or After Surgery for Patients with Brain Cancer Spread

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05438212

Provider View

This study is exploring whether giving radiation therapy before or after surgery is more effective for patients with cancer that has spread to the brain. The trial aims to see if this approach can better control the cancer and reduce symptoms.

Patient Parameters

Program Overview

This phase III trial is investigating the best timing for stereotactic radiosurgery (a precise form of radiation therapy) in treating patients with brain metastases, which is cancer that has spread to the brain. The study compares the effects of giving this radiation either before or after surgery to see which method is more effective in stopping tumor growth and reducing symptoms.

Description

The main goal of this study is to find out if giving radiation therapy before surgery can improve outcomes for patients with brain metastases compared to giving it after surgery. Researchers will look at how well the cancer is controlled, how long patients live, and any side effects from the treatment. They will also assess how the treatment affects patients' symptoms and cognitive function.

Patients in the study will be randomly assigned to one of two groups. One group will have surgery first, followed by radiation therapy within 10-30 days. The other group will receive radiation therapy within 7 days before surgery. After treatment, patients will be monitored every 3 months for 2 years, and then every 6 months for another 2 years.

The study will also explore if the type of surgery affects the risk of cancer spreading to the brain's protective layers. Researchers will compare the rates of cancer returning in the brain and any side effects between the two groups.

Eligibility Criteria

Inclusion Criteria

  • Have 1-4 brain metastases confirmed by MRI, with at least one needing surgery.
  • The tumor to be removed must be between 2.0 cm and 5.0 cm in size.
  • Other tumors must be less than 4.0 cm.
  • Have a history of cancer outside the brain diagnosed within the last 3 years.
  • All brain tumors must be more than 5 mm away from the optic chiasm and not in the brainstem.
  • Be medically fit for surgery and radiation therapy.
  • The tumor for surgery must be safely removable by the surgeon.
  • Have a physical exam within 14 days before joining the study.
  • Be 18 years or older.
  • Have a Karnofsky performance status of 60 or higher.
  • Women of childbearing potential must have a negative pregnancy test within 14 days before joining.
  • Agree to use contraception during the study.
  • Provide informed consent and allow the release of health information.

Exclusion Criteria

  • Have had previous brain radiation therapy, including whole brain radiation or radiosurgery to the surgery site.
  • Have leptomeningeal disease, which is cancer spread to the brain's protective layers.
  • Have medical conditions that make the study treatment unsafe, such as issues with anesthesia or surgery.
  • Have a primary cancer type of germ cell tumor, small cell carcinoma, or lymphoma.
  • Have more than one brain tumor planned for surgery.
  • Cannot undergo MRI with contrast.
  • Plan to receive certain chemotherapy or targeted therapy within 3 days before, on the day of, or 3 days after radiation therapy.

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