The NeoGlioma Study

Overview

About this study

This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Clear clinical and radiographic evidence of primary HGG as judged by the Mayo multidisciplinary neuro-oncology team (WHO grade III-IV, including glioblastoma) regardless of IDH and MGMT status.
  • 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.
  • ECOG Performance Status (PS) ≤ 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.
  • Patients must have adequate biological parameters as demonstrated by the following blood counts at initial screening obtained ≤ 14 days prior to starting treatment:
    • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
    • Platelet count ≥ 80,000/mm^3 (80 × 10^9/L);
    • Hemoglobin (Hgb) ≥ 9 g/dL.

Exclusion Criteria:

  • 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.
  • 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.
  • 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.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Daniel Trifiletti, M.D.

Contact us for the latest status

Contact information:

Jacquelyn Gardner M.B.A.

Gardner.Jacquelyn@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20519962

Mayo Clinic Footer