This phase II trial investigates how well GLIADEL wafers after surgery work compared to stereotactic radiosurgery after surgery in treating patients with cancer that has spread to the brain (metastatic brain tumor). GLIADEL is a wafer that is used to deliver the anticancer drug carmustine directly into a brain tumor site after the tumor has been removed by surgery. Chemotherapy drugs, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic radiosurgery uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving GLIADEL or stereotactic radiosurgery after surgery may help keep the cancer from coming back.
Additional locations may be listed on ClinicalTrials.gov for NCT04222062.
Locations matching your search criteria
United States
Nebraska
Omaha
University of Nebraska Medical CenterStatus: Active
Contact: Michele Renee Aizenberg
Phone: 402-559-9614
PRIMARY OBJECTIVE:
I.To evaluate, in a phase II non-inferiority study, the efficacy of carmustine implant (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 OBJECTIVES:
I. To evaluate the intracranial progression-free survival of patients with metastatic lesions to the brain treated with or without the insertion of GLIADEL wafers (as determined by the operative site).
II. To evaluate the neurocognitive status of patients undergoing surgical intervention and insertion of GLIADEL wafers or adjuvant SRS in patients with metastatic brain cancer.
OTHER OBJECTIVE:
I. To obtain tissue from primary and metastatic sites and blood to determine the differences in the genome between the metastatic brain tumor, the primary tumor, and the germline to assess mutations over time.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: During surgical resection, patients receive carmustine implant. Within 6 weeks after surgical resection, patients undergo SRS to any other lesions. Additionally, patients undergo blood sample collection and magnetic resonance imaging (MRI) of the brain throughout the study.
ARM II: Within 6 weeks after surgical resection, patients undergo SRS to the resection bed and any other lesions. Additionally, patients undergo blood sample collection and MRI of the brain throughout the study.
After completion of study treatment, patients are followed up at 3 months, every 3 months in year 1, every 4 months in year 2, and then every 6 months in year 3.
Lead OrganizationUniversity of Nebraska Medical Center
Principal InvestigatorMichele Renee Aizenberg