Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial
Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study
Mayo Clinic
28 participants
May 23, 2023
INTERVENTIONAL
Conditions
Summary
This phase I 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.
Eligibility
Inclusion Criteria11
- 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 Criteria15
- 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
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Interventions
Undergo radiation therapy
Undergo radiosurgery
Undergo MRI-guided stereotactic biopsy
Drug
Undergo TTF
Undergo MRI
Undergo blood sample collection
Undergo biopsy
Undergo surgery
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05030298