Study Comparing Post-Surgery Radiation Treatments for Brain Tumors: Stereotactic Radiotherapy vs. GammaTile

Sponsor: GT Medical Technologies, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04365374

Provider View

This clinical trial is comparing two types of radiation treatments given after surgery for brain tumors. It aims to find out which method is more effective and safer for patients with brain metastases.

Patient Parameters

Program Overview

This study is testing two different radiation treatments for patients who have had surgery to remove brain tumors that have spread from other parts of the body. One treatment uses GammaTiles, which are small tiles that deliver radiation directly to the area where the tumor was removed. The other treatment is stereotactic radiotherapy (SRT), which is given 3-4 weeks after surgery and is the current standard treatment. The trial will compare how well each treatment works in controlling the cancer, improving survival, and maintaining quality of life.

Description

The trial will involve patients who have recently been diagnosed with brain metastases and are undergoing surgery to remove one of the tumors. After surgery, patients will receive either GammaTile therapy or stereotactic radiotherapy (SRT) to the area where the tumor was removed. GammaTile therapy delivers radiation directly to the tumor site during surgery, while SRT is given a few weeks later. The study will compare the two treatments in terms of their effectiveness in controlling the cancer, improving survival rates, and maintaining patients' quality of life and cognitive function. Participants will be randomly assigned to one of the two treatment groups. The study will also look at the safety of each treatment and any side effects that may occur. The goal is to gather more data to support the use of GammaTile therapy as a new method for treating brain metastases.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years and older.
  • Diagnosed with 1 to 4 new brain metastases from a cancer that started outside the brain.
  • One tumor, called the index lesion, is planned for surgical removal and is between 2.5 cm and 5.0 cm in size.
  • Other tumors must be less than 4.0 cm in size and will be treated with SRT.
  • Tumors must be located more than 5 mm away from the optic chiasm and not in the brainstem.
  • Previous or current treatment with certain cancer therapies is allowed, following specific guidelines.
  • A performance status score of 70 or higher, indicating the ability to care for oneself.
  • Stable overall health with a life expectancy of at least 6 months.
  • Ability to undergo an MRI scan of the head.
  • Adequate kidney and liver function for surgery.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Willingness to use effective birth control during the study and for a period after treatment.
  • Ability to speak English or Spanish, as English speakers will complete cognitive tests.
  • Willingness to provide written consent to participate in the study.

Exclusion Criteria

  • Under 18 years old.
  • Performance status score below 70.
  • Previous radiation or surgery to the index tumor or new tumors, except for up to 2 prior SRT treatments to other tumors.
  • More than 4 new brain metastases.
  • Pregnant women.
  • Certain types of cancer, such as germ cell tumors, small cell carcinoma, or lymphoma.
  • Cancer spread to the lining of the brain (leptomeningeal metastasis).
  • Previous whole-brain radiation therapy for brain metastases.
  • Other treatments that might interfere with the study.
  • Psychiatric or neurological conditions affecting cognition that might impact participation.
  • Inability to understand the study or provide informed consent.

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