Preoperative Radiosurgery for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that you cannot have used systemic anti-cancer therapy in the previous 3 months.
Is preoperative radiosurgery for brain tumors generally safe in humans?
Research on advanced radiotherapy techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) shows that these methods are generally safe, with some risk of side effects such as gastrointestinal and genitourinary issues in prostate cancer treatment. These techniques are widely used and considered safe in clinical practice for various conditions.12345
How is preoperative radiosurgery for brain tumors different from other treatments?
Preoperative radiosurgery for brain tumors is unique because it involves delivering a focused, high dose of radiation to the tumor before surgery, which can help shrink the tumor and make it easier to remove. This approach can also protect healthy brain tissue and allow for quicker recovery and transition to other treatments compared to traditional post-surgery radiation.678910
What data supports the effectiveness of the treatment Preoperative Radiosurgery for Brain Tumor?
Research shows that stereotactic radiosurgery (SRS), a key component of the treatment, is effective for brain metastases by focusing radiation precisely on the tumor, which helps preserve healthy brain tissue and improve outcomes. Additionally, intraoperative radiotherapy (IORT) has shown benefits in preventing tumor regrowth and allowing quicker progression to other treatments.910111213
Who Is on the Research Team?
Daniel Trifiletti, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Adults with high grade glioma (brain tumor) who are planning surgery and radiotherapy, have good blood counts, no prior cranial radiotherapy, can perform daily activities with minimal help (ECOG PS ≤2), not pregnant or nursing, agree to use contraception if of childbearing potential, and can provide consent. Excludes those with non-MRI compatible devices, recent cancer therapy within 3 months, medical issues preventing surgery or known low-grade gliomas.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Radiosurgery
Patients undergo MRI-guided stereotactic biopsy and preoperative radiosurgery in 1 fraction
Surgery
Patients undergo surgery within 14 days after radiosurgery
Postoperative Radiation and Chemotherapy
Patients receive standard of care radiation therapy over 30 fractions and temozolomide daily with or without tumor treating fields
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Radiation Therapy
- Radiosurgery
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator