preoperative radiosurgery for the treatment of high grade glioma, neoglioma trial

Conditions: Malignant Glioma

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.

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.

Eligibility criteria:
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