A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease
University of Nebraska
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.
Description
This study is being done to assess the efficacy of GLIADEL, a local chemotherapy, in preventing local recurrence of a metastatic brain tumor compared to stereotactic radiosurgery (SRS) after resection. 100 adult participants with one to four metastatic brain tumors with one tumor needing resection will be enrolled. Participants with prior radiation, lymphoma, small cell, germ cell, unknown primary, or anaplastic thyroid diagnoses will be ineligible. Life expectancy should be greater than 3 months. Participants will be randomized at the time of surgery to 1) GLIADEL placement at the time of r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * 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 permit…
Interventions
- DrugCarmustine 7.7Mg Wafer
GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.
Locations (2)
- Henry FordDetroit, Michigan
- University of Nebraska Medical CenterOmaha, Nebraska