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

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05030298

Patient View

This phase I/IIA trial evaluates the safety of preoperative radiosurgery in high-grade glioma patients. Eligibility includes adults with WHO grade III-IV gliomas, ECOG PS 0-2, and no prior cranial radiotherapy. Interventions involve radiosurgery, surgery, radiation therapy, temozolomide, and optional TTF. Patients provide tissue/blood samples and are followed for up to 5 years.

Patient Parameters

Program Overview

This phase I/IIA 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.

Description

PRIMARY OBJECTIVE:

I. To evaluate the safety 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: Patients are assigned to 1 of 2 cohorts.

COHORT A: Patients undergo magnetic resonance imaging (MRI)-guided stereotactic biopsy. Patients then undergo radiosurgery over 1 fraction. Within 14 days, patients undergo surgery. Within 4-6 weeks, 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.

COHORT B: Patients undergo surgery. Within 4-6 weeks, 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 on study.

After completion of study treatment, patients are followed up every 2-3 months for up to 5 years.

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 to either cohort if a further resection is planned
  • 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
  • No prior history of cranial radiotherapy
  • 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
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Provide written informed consent
  • Planning to receive adjuvant radiotherapy at enrolling institution
  • Willing to provide tissue and/or blood samples for correlative research purposes
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to registration)
  • Platelet count >= 80,000/mm^3 (80 x 10^9/L) (obtained =< 14 days prior to registration)
  • Hemoglobin (Hgb) >= 9 g/dL (=< 14 days prior to registration)

Exclusion Criteria

  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception

  • 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

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