A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease
- Registration Number
- NCT04222062
- Lead Sponsor
- University of Nebraska
- Brief 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.
- Detailed 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 resection or 2) SRS post-operatively to the resection cavity. Any other tumors (up to three) will have SRS as their primary treatment after surgery. SRS will take place within 6 weeks from surgery.
Participants will be evaluated pre-operatively with Magnetic resonance imaging (MRI) brain and neuropsychological testing and will have immediate post-op MRI for extent of resection (EOR) determination. Participants will have SRS to the resection cavity if no GLIADEL was placed and all will have SRS to any other lesions. They will be followed at set intervals to evaluate for local recurrence and neurocognitive changes. The genome of the metastatic brain tumor will be compared to their primary and germline for identification of alterations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GLIADEL Arm Carmustine 7.7Mg Wafer Once the tumor has been removed, GLIADEL wafers will be applied to the resection cavity. The number of wafers used will be determined by the size of the cavity. Enough wafers should be used so that as much of the cavity is covered as possible.
- Primary Outcome Measures
Name Time Method Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS) 12 months The primary outcome is to evaluate the efficacy of GLIADEL local chemotherapy compared to Stereotactic Radiosurgery (SRS) in preventing local recurrence after resection of a metastatic brain tumor (local recurrence at surgical site).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Henry Ford
🇺🇸Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States