Study on Using Stereotactic Radiosurgery Before or After Surgery for Treating Brain Tumors from Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03750227

Provider View

This clinical trial is exploring the effects and safety of using a precise radiation treatment called stereotactic radiosurgery (SRS) either before or after surgery in patients with brain tumors that have spread from other parts of the body or can be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to find out how well stereotactic radiosurgery (SRS), a type of targeted radiation therapy, works when given before or after surgery in patients with brain tumors that have spread from other areas of the body. SRS delivers a high dose of radiation directly to the tumor, potentially causing less harm to surrounding healthy tissue.

Description

The main goal of this study is to see if giving stereotactic radiosurgery (SRS) before surgery can delay the return of brain tumors or reduce complications compared to giving SRS after surgery. Researchers will also look at whether patients live longer, have a better quality of life, and complete their planned treatments more successfully when SRS is given before surgery. Additionally, the study will examine if starting other cancer treatments sooner is possible with pre-surgery SRS.

The study will also explore if pre-surgery SRS leads to fewer side effects like radiation damage to the brain, and if it reduces the chance of cancer spreading to the brain's lining or returning to the same spot.

Researchers will also study the genetic changes in tumors after radiation and how these changes might help predict treatment success.

Participants will be randomly assigned to one of two groups:

  • Group A: Surgery first, followed by SRS within two weeks.
  • Group B: SRS first, followed by surgery within four weeks.

After treatment, participants will have follow-up visits at two weeks, then every 3-4 months for up to two years, and periodically for up to three years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of cancer that has spread to the brain, based on medical tests.
  • Need surgery to remove one brain tumor, as recommended by a neurosurgeon.
  • Plan to receive stereotactic radiosurgery for all brain tumors needing treatment (up to 10 tumors).
  • Be in good overall health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Provide written informed consent or have a legal representative do so.
  • Agree to attend follow-up visits and provide medical records and imaging if follow-up is done elsewhere.

Exclusion Criteria

  • Pregnant or nursing women, or those not using effective birth control.
  • Have severe health conditions that could interfere with the study.
  • Have a weakened immune system or are HIV positive and on antiretroviral therapy.
  • Have uncontrolled illnesses like heart failure or psychiatric conditions.
  • Have had previous brain surgery for cancer.
  • Have certain types of cancer like germ cell tumors or lymphoma.
  • Have had whole brain radiation therapy before.
  • Have allergies to MRI contrast or have non-MRI-safe implants.
  • Have cancer spread to the brain's lining.
  • Have a brain tumor too close to the optic chiasm or larger than 5 cm.
  • Have more than 10 brain tumors.
  • Need surgery for more than one brain tumor.
  • Need long-term steroid or bevacizumab treatment.
  • Are part of another brain tumor study involving radiation or surgery.

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