RecruitingPhase 2NCT04222062

A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease


Sponsor

University of Nebraska

Enrollment

100 participants

Start Date

Nov 6, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for patients who have cancer that has spread to the brain: a chemotherapy wafer (GLIADEL) placed directly in the brain after surgery, versus a targeted radiation technique called stereotactic radiosurgery. The goal is to find which approach better controls brain tumors. **You may be eligible if...** - You are 18 or older - You have a solid cancer (such as lung or breast cancer) that has spread to the brain - You have 1 to 4 brain tumors, each no larger than 4 cm, and surgery is planned for at least one - You are in reasonably good health (Karnofsky score 60 or above) - Your expected survival is at least 3 months - Your blood clotting tests are normal **You may NOT be eligible if...** - You have had prior radiation to that area of the brain or whole-brain radiation - Your cancer is lymphoma, germ cell cancer, small cell lung cancer, or anaplastic thyroid cancer - You have a neurodegenerative disorder like dementia - Your tumor is larger than 4 cm - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarmustine 7.7Mg Wafer

GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.


Locations(2)

Henry Ford

Detroit, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT04222062


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