Preoperative radiosurgery for high grade glioma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I trial investigates the feasibility, safety, and maximum tolerated dose of preoperative radiosurgery in patients with biopsy-proven high-grade glioma. The approach involves using MRI-guided stereotactic biopsy followed by a single large dose of radiation to the tumor before conventional surgery. The study aims to evaluate the acute toxicity profile, radiographic tumor control, and overall survival rates post-surgery. Additionally, it includes correlative research to understand tumor repair pathways and immune profiling.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Arizona
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Daniel M. Trifiletti, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.