25 Participants Needed

Preoperative Radiosurgery for Brain Tumor

CT
Overseen ByClinical Trials Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.678910

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.35111213

Research Team

DM

Daniel Trifiletti, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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 โ‰ค2), 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

Provide written informed consent
Ability to complete questionnaire(s) by themselves or with assistance
Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only
See 10 more

Exclusion Criteria

I am willing to participate in the study.
Investigator discretion that enrollment on the study would pose undo harm or risk to the patient
I am currently breastfeeding.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Preoperative Radiosurgery

Patients undergo MRI-guided stereotactic biopsy and preoperative radiosurgery in 1 fraction

2 weeks
1 visit (in-person)

Surgery

Patients undergo surgery within 14 days after radiosurgery

2 weeks
1 visit (in-person)

Postoperative Radiation and Chemotherapy

Patients receive standard of care radiation therapy over 30 fractions and temozolomide daily with or without tumor treating fields

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Every 2-3 months for 12 months, then every 3 months up to 3 years

Treatment Details

Interventions

  • Radiation Therapy
  • Radiosurgery
Trial Overview The NeoGlioma Study is testing the effectiveness of radiosurgery before conventional brain tumor surgery. The goal is to see if this approach improves tumor control while reducing side effects compared to traditional methods that involve multiple radiation doses over a longer period.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (stereotactic biopsy, radiosurgery, surgery)Experimental Treatment9 Interventions
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
๐Ÿ‡จ๐Ÿ‡ณ
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
๐Ÿ‡จ๐Ÿ‡ญ
Approved in Switzerland as Radiation Therapy for:
  • 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

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Intensity-modulated stereotactic radiotherapy (IMSRT) provides better conformity and coverage for planning target volumes (PTV) compared to stereotactic conformal radiotherapy (SCRT), especially for irregular and multifocal lesions, based on a study of 10 patients.
IMSRT also offers improved sparing of organs at risk (OAR), resulting in lower doses to these critical areas, although it may increase the volume of normal tissue receiving a low dose.
Intensity-modulated stereotactic radiotherapy vs. stereotactic conformal radiotherapy for the treatment of meningioma located predominantly in the skull base.Baumert, BG., Norton, IA., Davis, JB.[2022]
In a study of 379 patients with non-metastatic Stage III-IV head and neck squamous cell cancer, IMRT with simultaneous integrated boost (IMRT+SIB) showed similar effectiveness in local control and survival rates compared to traditional 3D conformal radiotherapy (3D-CRT) and sequential IMRT (IMRTseq).
IMRT+SIB significantly reduced acute toxicity, with lower rates of severe mucositis, dermatitis, and the need for feeding tubes during treatment, suggesting it is a safer option for patients undergoing chemoradiation.
Comparison of 3D confromal radiotherapy and intensity modulated radiotherapy with or without simultaneous integrated boost during concurrent chemoradiation for locally advanced head and neck cancers.Spiotto, MT., Weichselbaum, RR.[2021]
The combination of stereotactic radiosurgery (SRS) and whole-brain radiotherapy (WBRT) improves local tumor control and neurological function in patients with brain metastases, particularly benefiting those with a single metastasis, as it is associated with better survival compared to WBRT alone.
Current studies on SRS compared to other treatments like WBRT or neurosurgery show limited quality and inconclusive evidence, highlighting the need for more rigorous research to assess the effectiveness and safety of these interventions.
Medical and health economic assessment of radiosurgery for the treatment of brain metastasis.Mรผller-Riemenschneider, F., Schwarzbach, C., Bockelbrink, A., et al.[2021]

References

Intensity-modulated stereotactic radiotherapy vs. stereotactic conformal radiotherapy for the treatment of meningioma located predominantly in the skull base. [2022]
Comparison of 3D confromal radiotherapy and intensity modulated radiotherapy with or without simultaneous integrated boost during concurrent chemoradiation for locally advanced head and neck cancers. [2021]
Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. [2021]
Cumulative volumetric analysis as a key criterion for the treatment of brain metastases. [2018]
Outcome assessment of intraoperative radiotherapy for brain metastases: results of a prospective observational study with comparative matched-pair analysis. [2023]
6.Czech Republicpubmed.ncbi.nlm.nih.gov
Long-Term Clinical Results of IGRT in Prostate Cancer Treatment. [2021]
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]
A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. [2022]
Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. [2018]
Functional intercomparison of intraoperative radiotherapy equipment - Photon Radiosurgery System. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Intracranial intraoperative radiotherapy (IORT): evaluation of electrocorticography and peri-operative seizure risk. [2023]
Resection of supratentorial brain metastases with intraoperative radiotherapy. Is it safe? Analysis and experiences of a single center cohort. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity