Stereotactic Radiosurgery for Brain Cancer
(NASRS Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byDavid Shultz, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Must not be taking: Cytotoxic chemotherapy
Disqualifiers: Pregnancy, Prior cranial radiotherapy, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
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).
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.
+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.
+3 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Neoadjuvant SRS
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Health NetworkToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Stereotactic radiosurgery as an adjunct to surgery and external beam radiotherapy in the treatment of patients with malignant gliomas. [2022]To evaluate the efficacy and toxicity of a stereotactic radiosurgery boost as part of the primary management of a minimally selected population of patients with malignant gliomas.
Radiosurgery in the initial management of malignant gliomas: survival comparison with the RTOG recursive partitioning analysis. Radiation Therapy Oncology Group. [2022]To evaluate the impact of stereotactic radiosurgery on the survival of patients treated with malignant gliomas.
Predicting the outcome of radiotherapy in brain metastasis by integrating the clinical and MRI-based deep learning features. [2023]A considerable proportion of metastatic brain tumors progress locally despite stereotactic radiation treatment, and it can take months before such local progression is evident on follow-up imaging. Prediction of radiotherapy outcome in terms of tumor local failure is crucial for these patients and can facilitate treatment adjustments or allow for early salvage therapies.
Stereotactic Radiosurgery Keeps Brain Metastases at Bay. [2018]According to two clinical trials presented at the American Society for Radiation Oncology's 2016 annual meeting, stereotactic radiosurgery following surgical removal of brain metastases decreases the risk of local recurrence and, compared with whole-brain radiotherapy, offers patients a better quality of life. As such, postoperative stereotactic radiosurgery should be considered a new standard of care for patients whose cancer has spread to the brain.
Pattern of disease progression following stereotactic radiosurgery in malignant glioma patients. [2020]The clinical benefit of stereotactic radiosurgery (SRS) in the treatment of malignant glioma remains controversial. We analyzed failure patterns of malignant gliomas following SRS to identify the clinical implications of SRS against these malignancies.
Risk of radiation-associated intracranial malignancy after stereotactic radiosurgery: a retrospective, multicentre, cohort study. [2020]A major concern of patients who have stereotactic radiosurgery is the long-term risk of having a secondary intracranial malignancy or, in the case of patients with benign tumours treated with the technique, the risk of malignant transformation. The incidence of stereotactic radiosurgery-associated intracranial malignancy remains unknown; therefore, our aim was to estimate it in a population-based study to assess the long-term safety of this technique.
Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. [2021]Efficacy and safety of the own single-center experience with moderately dosed radiosurgery (SRS) for limited (one to four) brain metastases were analyzed and correlated with patient- and treatment-related variables.
Predictors of response to Gamma Knife radiosurgery for intracranial meningiomas. [2022]In this paper, the authors' aim was to determine short-term volumetric and diametric tumor growth and identify clinical, radiological, and dosimetric predictors of adverse radiation events (AREs) following stereotactic radiosurgery (SRS) for intracranial WHO Grade I meningiomas.
Safety of radiosurgery concurrent with systemic therapy (chemotherapy, targeted therapy, and/or immunotherapy) in brain metastases: a systematic review. [2021]Stereotactic radiosurgery (SRS) is a standard option for brain metastases (BM). There is lack of consensus when patients have a systemic treatment, if a washout is necessary. The aim of this review is to analyze the toxicity of SRS when it is concurrent with chemotherapies, immunotherapy, and/or targeted therapies. From Medline and Embase databases, we searched for English literature published up to April 2020 according to the PRISMA guidelines, using for key words the list of the main systemic therapies currently in use And "radiosurgery," "SRS," "GKRS," "Gamma Knife," "toxicity," "ARE," "radiation necrosis," "safety," "brain metastases." Studies reporting safety or toxicity with SRS concurrent with systemic treatment for BM were included. Of 852 abstracts recorded, 77 were included. The main cancers were melanoma, lung, breast, and renal carcinoma. These studies cumulate 6384 patients. The median SRS dose prescription was 20 Gy [12-30] .For some, they compared a concurrent arm with a non-concurrent or a SRS-alone arm. There were no skin toxicities, no clearly increased rate of bleeding, or radiation necrosis with significant clinical impact. SRS combined with systemic therapy appears to be safe, allowing the continuation of treatment when brain SRS is considered.
Management of adverse radiation effects after radiosurgery. [2012]Stereotactic radiosurgery (SRS) is a well-established tool in the armamentarium for the treatment of metastatic tumors to the brain. Although SRS has proven to be highly effective in the management of brain metastases, it is not without risk. Despite selective targeting of lesions and the sharp dose fall-off associated with radiosurgical treatments, adverse radiation effects (AREs) can and do occur, albeit at a low rate, just as has been reported after conventional fractionated radiation therapy. One of the most vexing clinical scenarios for SRS practitioners is the distinction between ARE and tumor recurrence or progression after radiosurgery. Differentiation of these two entities is critical, as further treatment options range from oral medications to invasive surgical resection. In this review, we define AREs and discuss the possible mechanisms that produce them. Efforts to distinguish between ARE and tumor progression also are explored. Finally, a management algorithm for AREs is proposed.
Stereotactic radiosurgery for brain metastases from breast cancer. [2019]Stereotactic radiosurgery is an alternative to resection or to radiotherapy alone for patients with brain metastases. Outcomes after radiosurgery for patients with brain metastases specifically from breast cancer have not been defined.
Stereotactic Radiosurgery for Multiple Brain Metastases. [2020]To give an overview on the current evidence for stereotactic radiosurgery of brain metastases with a special focus on multiple brain metastases.
Neoadjuvant stereotactic radiosurgery for brain metastases: a new paradigm. [2023]For patients with surgically accessible solitary metastases or oligometastatic disease, treatment often involves resection followed by postoperative stereotactic radiosurgery (SRS). This strategy has several potential drawbacks, including irregular target delineation for SRS and potential tumor "seeding" away from the resection cavity during surgery. A neoadjuvant (preoperative) approach to radiation therapy avoids these limitations and offers improved patient convenience. This study assessed the efficacy of neoadjuvant SRS as a new treatment paradigm for patients with brain metastases.
Radiobiology of brain metastasis: applications in stereotactic radiosurgery. [2019]Stereotactic radiosurgery is a neurosurgical modality in which a target lesion can be irradiated while sparing normal brain tissue. In some respects, brain metastasis is well suited for radiosurgery, as metastatic lesions tend to be small and well circumscribed and displace (but do not infiltrate) normal brain tissue, facilitating the delivery of radiation. Advances in stereotactic radiosurgical planning, such as blocking patterns and beam shaping, have allowed further targeting of discrete lesions while minimizing the effect of radiation toxicity on the central nervous system. In this paper the authors review the radiobiology of brain metastases and stereotactic radiosurgical approaches that can be used to treat these tumors safely.
Factors related to the local treatment failure of γ knife surgery for metastatic brain tumors. [2010]Radiosurgery (RS) is regarded as a standard therapy for metastatic brain tumors, but local failure requiring repeated therapy for the same lesion remains an unsolved problem. The authors analyzed outcomes of gamma knife surgery (GKS) for metastatic lesions to identify factors of local treatment failure.