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

Launched by MAYO CLINIC · Aug 26, 2021

Keywords

ClinConnect Summary

The NeoGlioma Trial is a clinical study designed to see if giving a single high dose of radiation therapy, known as radiosurgery, before surgery can help patients with high-grade glioma, a type of brain tumor. This approach aims to target the tumor more precisely, potentially leading to better control of the tumor while causing less damage to healthy brain tissue. The study is currently recruiting participants who are 18 years or older and have been diagnosed with high-grade glioma, such as glioblastoma, confirmed by a previous biopsy. Participants must also be scheduled for tumor surgery and not have any significant health risks that would complicate receiving radiation treatment.

If you join this trial, you can expect to undergo the radiosurgery as a part of your treatment before your scheduled surgery. The study will also involve completing some questionnaires and providing samples for research purposes. It's important to know that women who are pregnant or nursing, as well as those who have certain health conditions or previous treatments, may not be eligible to participate. This trial aims to improve treatment outcomes for patients with high-grade glioma, and your involvement could contribute to valuable research in this area.

Gender

ALL

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
• • 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