30 Participants Needed

Stereotactic Radiosurgery for Brain Cancer

(NASRS Trial)

Recruiting at 1 trial location
DS
Overseen ByDavid Shultz, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had cytotoxic chemotherapy within 7 days before the treatment. Other medications, like targeted therapies, may be allowed at the discretion of your doctor.

What data supports the effectiveness of the treatment Neoadjuvant Stereotactic Radiosurgery for brain cancer?

Research shows that stereotactic radiosurgery, when used after surgery for brain metastases (cancer spread to the brain), can reduce the risk of cancer coming back and improve quality of life compared to whole-brain radiotherapy. This suggests that stereotactic radiosurgery can be an effective treatment option for brain cancer.12345

Is stereotactic radiosurgery generally safe for treating brain conditions?

Stereotactic radiosurgery (SRS) is generally considered safe for treating brain conditions, though there is a low risk of adverse radiation effects (AREs), which can sometimes be confused with tumor progression. Long-term safety concerns include a potential risk of developing secondary brain tumors, but this risk is not well-defined. SRS combined with other treatments like chemotherapy appears to be safe without significant additional side effects.678910

How is neoadjuvant stereotactic radiosurgery different from other treatments for brain cancer?

Neoadjuvant stereotactic radiosurgery is unique because it is given before surgery, which helps avoid issues like irregular targeting and tumor spread during surgery, and offers more convenience for patients compared to the traditional approach of surgery followed by radiation.1112131415

What is the purpose of this trial?

This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).

Research Team

DS

David Shultz, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for patients with 1-6 brain metastases, where at least one tumor is large enough to consider surgery but hasn't been operated on yet. Participants must be able to undergo stereotactic radiosurgery (SRS), have a good performance status (ECOG ≤2), and not be pregnant or have certain conditions like widespread cancer in the spinal fluid or previous treatments that would exclude them.

Inclusion Criteria

My brain scan shows lesions smaller than 3.0 cm, and I have no immediate surgery planned.
I can take care of myself and am up and about more than half of my waking hours.
My MRI shows 1-6 cancer spots, with the largest no bigger than 3.0 cm.
See 3 more

Exclusion Criteria

My cancer is a type of metastatic germ cell tumor, small cell carcinoma, lymphoma, or brain tumor.
Inability to complete MRI with contrast of the head or known allergy to gadolinium
I have had brain radiation for my current cancer.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant stereotactic radiosurgery (NASRS) for brain metastases

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Regular visits as per study protocol

Long-term follow-up

Participants are monitored for survival and long-term outcomes

5 years

Treatment Details

Interventions

  • Neoadjuvant Stereotactic Radiosurgery
Trial Overview The study tests neoadjuvant stereotactic radiosurgery (NASRS) on patients with large brain tumors before any surgical intervention. It's a phase II trial focusing on those who haven't had their tumors removed yet and can tolerate this precise form of radiation therapy aimed at shrinking the tumors.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Neoadjuvant SRS

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Findings from Research

Stereotactic radiosurgery (SRS) was safely administered to 30 patients with malignant gliomas after standard radiotherapy, showing no significant acute or late toxicity, which suggests it is a feasible option for dose escalation in treatment.
The study reported a median survival of 13.9 months, with 1- and 2-year disease-specific survival rates of 57% and 25%, respectively, indicating that while SRS can be effective, further research is needed to fully understand its impact on long-term outcomes.
Stereotactic radiosurgery as an adjunct to surgery and external beam radiotherapy in the treatment of patients with malignant gliomas.Gannett, D., Stea, B., Lulu, B., et al.[2022]
In a study of 115 patients with malignant gliomas, the addition of stereotactic radiosurgery to conventional treatments significantly improved 2-year survival rates, particularly for patients in worse prognostic classes (classes 3-6).
The median survival for patients treated with radiosurgery was 96 weeks, compared to historical data showing lower survival rates, indicating that radiosurgery may enhance treatment outcomes, although further research through randomized trials is needed to confirm its role.
Radiosurgery in the initial management of malignant gliomas: survival comparison with the RTOG recursive partitioning analysis. Radiation Therapy Oncology Group.Sarkaria, JN., Mehta, MP., Loeffler, JS., et al.[2022]
A novel deep learning model using MRI and clinical data was developed to predict local control or failure of brain metastases after stereotactic radiation therapy, showing improved accuracy over standard clinical variables.
The best-performing model achieved an area under the curve (AUC) of 0.86, indicating strong predictive capability, particularly highlighting the significance of tumor margins in determining treatment outcomes.
Predicting the outcome of radiotherapy in brain metastasis by integrating the clinical and MRI-based deep learning features.Jalalifar, SA., Soliman, H., Sahgal, A., et al.[2023]

References

Stereotactic radiosurgery as an adjunct to surgery and external beam radiotherapy in the treatment of patients with malignant gliomas. [2022]
Radiosurgery in the initial management of malignant gliomas: survival comparison with the RTOG recursive partitioning analysis. Radiation Therapy Oncology Group. [2022]
Predicting the outcome of radiotherapy in brain metastasis by integrating the clinical and MRI-based deep learning features. [2023]
Stereotactic Radiosurgery Keeps Brain Metastases at Bay. [2018]
Pattern of disease progression following stereotactic radiosurgery in malignant glioma patients. [2020]
Risk of radiation-associated intracranial malignancy after stereotactic radiosurgery: a retrospective, multicentre, cohort study. [2020]
Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. [2021]
Predictors of response to Gamma Knife radiosurgery for intracranial meningiomas. [2022]
Safety of radiosurgery concurrent with systemic therapy (chemotherapy, targeted therapy, and/or immunotherapy) in brain metastases: a systematic review. [2021]
Management of adverse radiation effects after radiosurgery. [2012]
11.United Statespubmed.ncbi.nlm.nih.gov
Stereotactic radiosurgery for brain metastases from breast cancer. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Stereotactic Radiosurgery for Multiple Brain Metastases. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Neoadjuvant stereotactic radiosurgery for brain metastases: a new paradigm. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
Radiobiology of brain metastasis: applications in stereotactic radiosurgery. [2019]
Factors related to the local treatment failure of γ knife surgery for metastatic brain tumors. [2010]
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