Clinical Trial Finder

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) performance status (PS) 0, 1, or 2.

• - Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only.

Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test.

• - Ability to complete questionnaire(s) by themselves or with assistance.

• - Provide written informed consent.

• - Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration.

• - Willing to provide tissue and/or blood samples for correlative research purposes.

Exclusion Criteria:

• - Any of the following: - Pregnant women.

• - Nursing women who are unwilling to cease during therapy.

• - Men or women of childbearing potential who are unwilling to employ adequate contraception.

• - Prior history of cranial radiotherapy.

• - Unwillingness to participate in study.

• - Investigator discretion that enrollment on the study would pose undo harm or risk to the patient.

• - Non-MRI compatible implanted medical device.

• - Use of systemic anti-cancer therapy within the previous 3 months.

• - Medical contraindication to craniotomy and tumor resection.

• - Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor.

• - Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor.

• - Primary spinal cord glioma or primary brainstem glioma.

• - Residual tumor of excessive volume or eloquent location per investigator discretion.

- Patients who are unwilling or unable to comply with study procedures

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.

Arms

Experimental: Treatment (stereotactic biopsy, radiosurgery, surgery)

Patients undergo 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 TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.

Interventions

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