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

• Status: Not yet recruiting
• Trial end date: 2025-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Temozolomide

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

• 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) =< 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 starting treatment)

• Platelet count >= 80,000/mm^3 (80 x 10^9/L) (obtained =< 14 days prior to starting treatment)

• Hemoglobin (Hgb) >= 9 g/dL (=< 14 days prior to starting treatment)

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

• 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