NCT05030298

Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial

Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 radiation scan (RANO criteria). IV. Overall survival at 12 months following surgery. CORRELATIVE RESEARCH OBJECTIVE: I. Evaluation of the tumor repair pathways triggered by radiation, tumor vascular changes, tumor microenvironment immune profiling, cell cultures, and the creation of orthotopic xenograft models for future study. OUTLINE: This is a dose-escalation study. Patients undergo magnetic resonance imaging (MRI)-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without tumor treating fields (TTF) at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study. After completion of study treatment, patients are followed up every 2-3 months for 12 months and then every 3 months for up to 3 years after registration.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	Undergo radiation therapy
RADIATION	Radiosurgery	Undergo radiosurgery
PROCEDURE	Stereotactic Biopsy	Undergo MRI-guided stereotactic biopsy
DRUG	Temozolomide	Drug
PROCEDURE	Tumor Treating Fields Therapy	Undergo TTF
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2023-05-23
• Primary completion: 2027-09-15
• Completion: 2027-09-15
• First posted: 2021-09-01
• Last updated: 2025-11-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study