A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease
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.
• Age 18 years or older (in states with 18 as age of majority); Age 19 years or older in Nebraska (age of majority)
• Recursive partitioning analysis (RPA) class I, II or III with a Karnofsky Performance Status (KPS) of \>/ 60
• Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for at least one site with Gliadel placement planned for only one site
• Laboratory values adequate for patient to undergo surgery safely as determined by the attending neurosurgeon (transfusion permitted to reach goals)
• Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study. (No childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
• Normal coagulation studies (international normalized ratio, INR, ≤ 1.3)
• Estimated survival time of ≥ 3 months (determined by the participant's primary oncologist)
• Participant is willing and able to consent and abide by the protocol