Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study
Mayo Clinic
Summary
This phase I trial finds out the possible benefits and/or side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.
Description
PRIMARY OBJECTIVE: I. To evaluate the feasibility, safety and maximum tolerated dose (MTD) of preoperative radiosurgery in the treatment of patients with biopsy-proven high-grade glioma prior to conventional therapy. SECONDARY OBJECTIVES: I. Acute clinical toxicity profile using Common Terminology Criteria for Adverse Events (CTCAE) version 5 (defined as within 4 weeks of completion of postoperative radiotherapy. II. Radiographic tumor control at 12 months following surgery (per Response Assessment in Neuro-Oncology \[RANO\] criteria). III. Rate of pseudoprogression at first post radiatio…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 18 years * Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization \[WHO\] grade III-IV, including glioblastoma) regardless of IDH and MGMT status * Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment * Planned neurosurgical resection of tumor * Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection * Eastern Cooperative Oncology Group (ECOG) perfor…
Interventions
- RadiationRadiation Therapy
Undergo radiation therapy
- RadiationRadiosurgery
Undergo radiosurgery
- ProcedureStereotactic Biopsy
Undergo MRI-guided stereotactic biopsy
- DrugTemozolomide
Drug
- ProcedureTumor Treating Fields Therapy
Undergo TTF
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureBiospecimen Collection
Locations (2)
- Mayo Clinic in ArizonaPhoenix, Arizona
- Mayo Clinic in FloridaJacksonville, Florida