Preoperative radiosurgery for high grade glioma treatment
Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study
This study is testing if giving a high dose of radiation before surgery can help people with high-grade brain tumors feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Trial ID | NCT05030298 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the feasibility, safety, and maximum tolerated dose of preoperative radiosurgery in patients with biopsy-proven high-grade glioma. The approach involves using MRI-guided stereotactic biopsy followed by a single large dose of radiation to the tumor before conventional surgery. The study aims to evaluate the acute toxicity profile, radiographic tumor control, and overall survival rates post-surgery. Additionally, it includes correlative research to understand tumor repair pathways and immune profiling.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed high-grade glioma who are scheduled for neurosurgical resection.
Not a fit: Patients with low-grade gliomas or those who are not candidates for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve tumor control and reduce treatment-related side effects for patients with high-grade glioma.
How similar studies have performed: Other studies have shown promise with preoperative radiosurgery approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 1 other locations
- Mayo Clinic in Arizona — Phoenix, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Daniel M. Trifiletti, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.