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

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.

Interventions

• Radiation Therapy · RADIATION

  Undergo radiation therapy

• Radiosurgery · RADIATION

  Undergo radiosurgery

• Stereotactic Biopsy · PROCEDURE

  Undergo MRI-guided stereotactic biopsy

• Temozolomide · DRUG

  Drug

• Tumor Treating Fields Therapy · PROCEDURE

  Undergo TTF

• Magnetic Resonance Imaging · PROCEDURE

  Undergo MRI

• Biospecimen Collection · PROCEDURE

  Undergo blood sample collection

• Biopsy · PROCEDURE

  Undergo biopsy

• Therapeutic Conventional Surgery · PROCEDURE

  Undergo surgery

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (2)

• Mayo Clinic in Arizona, Phoenix, Arizona · RECRUITING
• Mayo Clinic in Florida, Jacksonville, Florida · RECRUITING