Trial Summary
What is the purpose of this trial?The phase I component of the study is to identify maximal tolerated dose (MTD). The phase II is to evaluate neurocognitive decline.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
What data supports the idea that Radiosurgery for Brain Metastases is an effective treatment?
The available research shows that stereotactic radiosurgery (SRS) is an effective treatment for brain metastases. It is often used instead of whole-brain radiation therapy (WBRT) because it improves outcomes and reduces side effects. For example, guidelines suggest that SRS is effective for patients with multiple brain metastases, and it is commonly used to treat 10 or more tumors in a single session. Additionally, SRS can be used after surgery to target large brain metastases, providing good control over the disease. In some cases, SRS alone is preferred over WBRT, as it does not decrease survival time and can be reserved for later use if needed.
12345What safety data is available for radiosurgery treatments like SRS and SBRT?
Safety data for radiosurgery treatments such as SRS and SBRT indicate that these procedures are generally safe with advancements in technology improving accuracy and reducing risks. The ASTRO Safety White Paper highlights the importance of quality and patient safety considerations due to the complexity and high doses involved. A study on CyberKnife radiosurgery for brain metastases in elderly patients shows it is effective and reduces neurotoxicity compared to whole brain radiation therapy. An analysis of CyberKnife incidents found that most led to little or no patient harm, with human performance being a common contributing factor. Overall, while there are risks, the safety profile of these treatments is favorable with ongoing efforts to improve safety practices.
36789Is Stereotactic Radiosurgery a promising treatment for brain metastases?
Yes, Stereotactic Radiosurgery (SRS) is a promising treatment for brain metastases. It is a focused radiation therapy that can be used instead of more invasive surgery or whole brain radiation. SRS is effective in controlling the growth of brain tumors and can be used as a primary treatment or alongside surgery. It has been shown to help improve survival and manage brain metastases from various cancers, including breast cancer.
210111213Eligibility Criteria
This trial is for adults over 18 with non-blood related cancers, like small cell lung carcinoma, who have six or more brain metastases but no larger than 4 cm. They should be relatively active (able to care for themselves) and not pregnant. They must agree to use birth control during the study. People with prior whole-brain radiation, leptomeningeal metastasis, a life expectancy under four months, or certain psychiatric conditions can't join.Inclusion Criteria
The biggest tumor is no larger than 4 centimeters.
You have not received a specific type of radiation treatment to the areas that will be treated in this study.
You are able to perform daily activities without help or only need a little help.
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Exclusion Criteria
You have received radiation treatment to your entire brain in the past.
You have cancer that has spread to the tissues surrounding the brain and spinal cord.
You are not expected to live for more than 4 months.
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Participant Groups
The trial is testing Stereotactic Radiosurgery (SRS), a precise form of radiation therapy aimed at brain tumors. The first phase determines the highest dose patients can take without serious side effects; the second phase looks at how this treatment affects patients' thinking and memory skills over time.
1Treatment groups
Experimental Treatment
Group I: RadiationExperimental Treatment1 Intervention
Stereotactic Radiosurgery
Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
🇺🇸 Approved in United States as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
- Liver tumors
- Lung tumors
- Spinal cord tumors
🇨🇦 Approved in Canada as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
🇯🇵 Approved in Japan as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
🇨🇳 Approved in China as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
🇨🇭 Approved in Switzerland as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Southwestern Medical CenterDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Potential role for LINAC-based stereotactic radiosurgery for the treatment of 5 or more radioresistant melanoma brain metastases. [2016]Linear accelerator (LINAC)-based stereotactic radiosurgery (SRS) is a treatment option for patients with melanoma in whom brain metastases have developed. Very limited data are available on treating patients with ≥5 lesions. The authors sought to determine the effectiveness of SRS in patients with ≥5 melanoma brain metastases.
Intracranial control after Cyberknife radiosurgery to the resection bed for large brain metastases. [2018]Stereotactic radiosurgery (SRS) is an alternative to post-operative whole brain radiation therapy (WBRT) following resection of brain metastases. At our institution, CyberKnife (CK) is considered for local treatment of large cavities ≥2 cm. In this study, we aimed to evaluate patterns of failure and characterize patients best suited to treatment with this approach.
Predictors of linear accelerator versus Gamma Knife stereotactic radiosurgery use for brain metastases in the United States. [2022]Stereotactic radiosurgery (SRS) for brain metastases is predominantly delivered via single-fraction Gamma Knife SRS (GKRS) or linear accelerator (LINAC) in up to five fractions. Predictors of SRS modality have been sparsely examined on a nationwide level.
Guidelines for Multiple Brain Metastases Radiosurgery. [2019]Stereotactic radiosurgery (SRS) is an effective treatment for patients with multiple brain metastases. Three decades of increasingly powerful scientific studies have shown that SRS improves outcomes and reduces toxicity when it replaces whole-brain radiation therapy (WBRT). Expert opinion surveys of clinicians have reported that the total intracranial tumor volume rather than the number of brain metastases is related to outcomes. As a result, an increasing number of treating and referring physicians have replaced the reflex use of WBRT with SRS, unless the patient has miliary disease or carcinomatous meningitis. In the current era of immunotherapy and targeted therapies with potentially increased systemic disease survival, 10 or more tumors are routinely treated with SRS alone at most academic medical centers. In a single SRS session we routinely treat patients with cumulative tumor volumes of 25 cm3 even if they have ≥10 metastases.
The role of radiosurgery in the management of malignant brain tumors. [2019]Stereotactic radiosurgery (SRS) provides the means for creating lesions in deep-seated areas of the brain inaccessible to invasive surgery, using single high doses of focused ionizing radiation, administered using stereotactic guidance. It is a surgical technique designed to produce a specific radiobiological effect within a sharply defined target region in a single treatment session. Its technical application requires a stereotactic coordinate system, highly accurate patient repositioning (usually fixed), and multiple convergent beams of photon radiation. SRS appears to provide no benefit in the upfront treatment of newly diagnosed malignant gliomas but may be used to effectively palliate small well-demarcated volumes of recurrent disease. For selected patients with brain metastases treated with whole-brain radiation therapy (WBRT), the addition of SRS improves median survival. In selected patients with brain metastases, it is also rational to withhold WBRT in favor of radiosurgery alone, with WBRT reserved for salvage without a decrease in median survival time.
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.
Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. [2022]This updated report on stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) is part of a series of consensus-based white papers previously published addressing patient safety. Since the first white papers were published, SRS and SBRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The complexity and submillimeter accuracy, and delivery of a higher dose per fraction requires an emphasis on best practices for technical, dosimetric, and quality assurance. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
Efficacy and safety of CyberKnife radiosurgery in elderly patients with brain metastases: a retrospective clinical evaluation. [2021]Stereotactic radiosurgery (SRS) has been increasingly applied for up to 10 brain metastases instead of whole brain radiation therapy (WBRT) to achieve local tumor control while reducing neurotoxicity. Furthermore, brain-metastasis incidence is rising due to the increasing survival of patients with cancer. Our aim was to analyze the efficacy and safety of CyberKnife (CK) radiosurgery for elderly patients.
Common Error Pathways in CyberKnife™ Radiation Therapy. [2020]Purpose/Objectives: Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) may be considered "high risk" due to the high doses per fraction. We analyzed CyberKnife™ (CK) SRS and SBRT-related incidents that were prospectively reported to our in-house incident learning system (ILS) in order to identify severity, contributing factors, and common error pathways. Material and Methods: From 2012 to 2019, 221 reported incidents related to the 4,569 CK fractions delivered (5.8%) were prospectively analyzed by our multi-professional Quality and Safety Committee with regard to severity, contributing factors, as well as the location where the incident occurred (tripped), where it was discovered (caught), and the safety barriers that were traversed (crossed) on the CK process map. Based on the particular step in the process map that incidents tripped, we categorized incidents into general error pathways. Results: There were 205 severity grade 1-2 (did not reach patient or no clinical impact), 11 grade 3 (clinical impact unlikely), 5 grade 4 (altered the intended treatment), and 0 grade 5-6 (life-threatening or death) incidents, with human performance being the most common contributing factor (79% of incidents). Incidents most commonly tripped near the time when the practitioner requested CK simulation (e.g., pre-CK simulation fiducial marker placement) and most commonly caught during the physics pre-treatment checklist. The four general error pathways included pre-authorization, billing, and scheduling issues (n= 119); plan quality (n= 30); administration of IV contrast during simulation or pre-medications during treatment (n= 22); and image guidance (n= 12). Conclusion: Most CK incidents led to little or no patient harm and most were related to billing and scheduling issues. Suboptimal human performance appeared to be the most common contributing factor to CK incidents. Additional study is warranted to develop and share best practices to reduce incidents to further improve patient safety.
Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. [2021]Radiotherapy for patients suffering from malignant neoplasms has developed greatly during the past decades. Stereotactic radiosurgery (SRS) is one important radiotherapeutic option which is defined by a single and highly focussed application of radiation during a specified time interval. One of its important indications is the treatment of brain metastases.
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.
CyberKnife Stereotactic Radiosurgery in brain metastases: A report from Latin America with literature review. [2022]Stereotactic radiosurgery is increasingly being employed for the treatment of brain metastases, both as an adjuvant to surgical resection, and also as a primary treatment modality. The aim of this study is to evaluate overall survival and local control in patients with brain metastases treated with CyberKnife Stereotactic Radiosurgery (CKRS), due to the lack of evidence reported in Latin America.
Long-term disease outcome and volume-based decision strategy in a large cohort of multiple brain metastases treated with a mono-isocentric linac-based Stereotactic Radiosurgery technique. [2021]Radiosurgery (SRS) is an effective treatment option for brain metastases (BMs). Long-term results of the first worldwide experience with a mono-isocentric, non-coplanar, linac-based stereotactic technique in the treatment of multiple BMs are reported.