Stereotactic Radiosurgery for Brain Cancer
(SRS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRobert Timmerman, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Disqualifiers: Leptomeningeal metastasis, Life expectancy < 3 months, Uncontrolled illness, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Stereotactic Radiosurgery for brain cancer?
Research shows that Stereotactic Radiosurgery (SRS) is effective for treating brain metastases, improving outcomes and reducing side effects compared to whole-brain radiation therapy. It is used successfully for various conditions, including large brain metastases and multiple brain tumors, with studies indicating its effectiveness in controlling tumor growth and improving patient outcomes.
12345Is stereotactic radiosurgery generally safe for humans?
Stereotactic radiosurgery (SRS) and related treatments like CyberKnife and Gamma Knife are generally considered safe, with most incidents leading to little or no patient harm. Safety studies show that errors are often related to human performance and administrative issues, rather than the treatment itself, and efforts are ongoing to improve safety practices.
678910How is the treatment Stereotactic Radiosurgery (SRS) unique for brain cancer?
Stereotactic Radiosurgery (SRS) is unique because it delivers a high dose of focused radiation to a specific area in the brain in a single session, minimizing damage to surrounding healthy tissue. This makes it an effective option for treating brain metastases and other intracranial lesions, especially in areas that are difficult to reach with traditional surgery.
111121314Eligibility Criteria
This trial is for adults with non-hematopoietic cancer and up to 10 brain metastases, none larger than 3.0 cm or in the brain stem. Participants must not be pregnant, agree to use contraception, have an ECOG score of ≤2 or Karnofsky score ≥50, and can have had prior treatments except recent brain surgery or radiation.Inclusion Criteria
I have 10 or fewer brain tumors.
My cancer is not related to blood, small cell lung, germ cell, or an unknown primary.
I have brain metastasis visible on MRI or CT scans.
+8 more
Exclusion Criteria
Patients with life expectancy < 3 months
I do not have any severe illnesses that could interfere with the study.
I am not pregnant or breastfeeding.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive stereotactic radiosurgery (SRS) with dose escalation to determine maximal tolerated doses
90 days
1 visit (in-person) for SRS procedure
Follow-up
Participants are monitored for safety, overall survival, time to progression, and local progression rate after treatment
3 years
Regular follow-up visits with imaging as per protocol
Participant Groups
The study tests increasing doses of Stereotactic Radiosurgery (SRS) on patients who haven't received previous brain radiation. The goal is to find higher tolerable doses that could improve treatment outcomes like tumor control and patient survival.
1Treatment groups
Experimental Treatment
Group I: Stereotactic RadiosurgeryExperimental Treatment1 Intervention
Radiation, Stereotactic Radiosurgery Dose-Escalation
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
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.
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.
Stereotactic radiosurgery and fractionated stereotactic radiosurgery for vestibular schwannomas: A comparison of clinical outcomes from the RSSearch patient registry. [2022]To compare clinical outcomes following stereotactic radiosurgery (SRS) and fractionated stereotactic radiosurgery (fSRS) for vestibular schwannomas (VS).
Linear accelerator radiosurgery in the treatment of brain metastases. [2022]To review a 12-year experience treating metastatic brain disease with linear accelerator-based stereotactic radiosurgery (SRS).
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.
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.
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.
Assessing the long-term safety and efficacy of gamma knife and linear accelerator radiosurgery for vestibular schwannoma: A systematic review and meta-analysis. [2022]Differences in long-term outcomes of single-fraction stereotactic radiosurgery (SRS) between gamma knife (GK) and linear accelerator (LINAC) systems for vestibular schwannoma (VS) management remain unclear. To investigate differences in safety and efficacy between modalities, we conducted a meta-analysis of studies over the past decade.
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.
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.
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.
Stereotactically guided radiosurgery using the linear accelerator. [2020]Leksell initiated the concept of stereotactic radiosurgery in 1951. This last decade has seen a rapid proliferation in the development of the methodology which is certainly related in part to the simultaneous growth of high-resolution neuro-imaging techniques. By focusing the beams of 201 hemispherically arrayed cobalt 60 sources, the gamma-knife delivers a high dose of radiation to a small target. Another possibility proposed by several authors is the bragg peak cyclotron-generated irradiation with accelerated protons or helium ions. In Lille, since 1988, we have chosen to develop stereotactic radiosurgery, according to the system of Betti, by the association of Talairach's stereotactic methodology and external single-dose encephalic irradiation with high energy X-rays, delivered by means of a linear accelerator. The major indication for the use of this method is an arteriovenous malformation. Stereotactic radiosurgery may be proposed alone or in combination with surgery and embolisation. It has been shown to be a potentially effective treatment and an attractive alternative in carefully selected patients with intracranial tumours: slow-growing, well limited, deep-seated tumours, such as some gliomas, acoustic neurinomas, skull base meningiomas, pituitary adenomas. This treatment is also used to deliver a focal boost of radiation to previously administered fractionated radiotherapy in patients with small gliomas and solitary brain 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.
The treatment of intracranial lesions with stereotactic radiosurgery. [2004]Stereotactic radiosurgery is a new method of delivering a high dose of megavoltage, ionizing radiation therapy to a localized area in the brain in a single session. A substantial variety of intracranial lesions can be treated with the use of a stereotactic head frame and set up of tertiary collimators on an existing linear accelerator. This state-of-the-art technique has been used since June 1992 at the Robert C. Byrd Health Sciences Center of West Virginia University in Morgantown. Radiosurgery treatment has been well tolerated by all 24 patients treated thus far.