Stereotactic Radiosurgery for Brain Cancer

Overseen By David Ostler

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Utah

Disqualifiers: Prior brain irradiation, Brain stem lesions, Leptomeningeal disease, Radiosensitive histology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safe radiation levels for people with brain cancer using stereotactic radiosurgery. The goal is to find the optimal dose to target brain tumors without prior radiation. It is designed for patients with 1 to 5 untreated brain metastases confirmed by CT or MRI scans. Participants must not have had previous brain radiation, and their tumors must be at least 3 cm apart. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new approach.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that if you are on active systemic cancer therapy, you should consult with your oncologist to ensure proper washout periods before starting the trial.

What prior data suggests that stereotactic radiosurgery is safe for brain cancer patients?

Research has shown that stereotactic radiosurgery (SRS) is a well-tolerated treatment for brain conditions, including cancer that has spread to the brain. Studies indicate it is a noninvasive procedure that delivers precise radiation to the brain, targeting the tumor while sparing most of the surrounding healthy tissue. This accuracy helps reduce side effects.

Evidence from past studies suggests that SRS is as effective as whole-brain radiotherapy (WBRT) in controlling cancer spread and improving survival rates. Patients generally handle SRS well, experiencing fewer long-term side effects compared to WBRT. This makes it a preferred choice for many, especially those wanting to avoid the broader effects of whole-brain treatments.

While the current trial is in an early phase and focuses on finding the safest dose, past experiences suggest that SRS is a promising and manageable option for patients with brain metastases. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic radiosurgery is unique because it offers a highly precise way to target brain cancer without the need for an actual surgical incision. Unlike traditional surgery or whole-brain radiation, this technique uses focused beams of radiation to attack tumors with pinpoint accuracy, minimizing damage to surrounding healthy tissue. Researchers are excited about this treatment because it has the potential to reduce side effects and recovery time significantly, making it a less invasive option for patients. Additionally, the ability to concentrate radiation on specific areas may enhance treatment effectiveness, offering hope for better outcomes compared to current standard treatments.

What evidence suggests that stereotactic radiosurgery might be an effective treatment for brain cancer?

Studies have shown that stereotactic radiosurgery (SRS), the treatment tested in this trial, effectively treats brain tumors that have spread from other parts of the body. This treatment uses focused radiation to target the tumor, protecting the surrounding healthy tissue. Research indicates that SRS can safely and precisely treat both non-cancerous and cancerous brain tumors. Clinical evidence supports its use as an important part of brain tumor treatment, offering patients a non-invasive option. Overall, SRS is recognized for its ability to control tumor growth and improve patient outcomes. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with 1-5 untreated brain metastases, each no larger than 40 mm. They must have a performance status indicating they can care for themselves and agree to use birth control during and after the study. People who've had prior brain radiation or whose tumors are in sensitive areas like the optic nerve or brain stem cannot join.

Inclusion Criteria

I am a man who can father a child and agree to use birth control during and for 3 months after radiation.

My brain scans show cancer spread.

I've had brain surgery, but my current brain lesion isn't in the same area.

Exclusion Criteria

I have multiple tumors that fit a full study group, and the study's early safety period isn't over.

My cancer type is known to respond well to radiation therapy.

I am pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic radiosurgery with dose escalation to determine the maximum tolerated dose

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Radiosurgery

Trial Overview The trial tests increasing doses of stereotactic radiosurgery (a precise form of radiation therapy) to find the highest dose patients with new brain metastases can tolerate without severe side effects.

How Is the Trial Designed?

Group I: Stereotactic Radiosurgery Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Stereotactic radiosurgery (SRS) is an effective non-invasive technique for targeting deep brain lesions with high doses of radiation, but it does not provide benefits for newly diagnosed malignant gliomas.

For patients with brain metastases, SRS can improve median survival when combined with whole-brain radiation therapy (WBRT), and in some cases, SRS alone may be a viable treatment option without compromising survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of radiosurgery in the management of malignant brain tumors. Stieber, VW., Ellis, TL.[2019]

Stereotactic radiosurgery is an innovative technique that delivers a high dose of radiation to specific areas in the brain in just one session, allowing for effective treatment of various intracranial lesions.

In a study involving 24 patients treated since June 1992, the procedure has been well tolerated, indicating a favorable safety profile for this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of intracranial lesions with stereotactic radiosurgery. Sinha, PP., Bloomfield, S., Smith, GK.[2004]

Stereotactic radiosurgery, particularly using high-energy X-rays and the gamma-knife technique, has become a promising treatment for conditions like arteriovenous malformations and certain slow-growing brain tumors, thanks to advancements in neuro-imaging and radiation delivery methods.

This treatment can be used alone or in combination with other therapies, such as surgery and embolization, and is effective for well-defined, deep-seated tumors, making it a valuable option for carefully selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactically guided radiosurgery using the linear accelerator. Blond, S., Coche-Dequeant, B., Castelain, B.[2020]

Stereotactic radiosurgery (SRS) for patients with 5 or more melanoma brain metastases showed a high local control rate of 91.3% at 6 months and 82.2% at 12 months, indicating its effectiveness as a treatment option.

The study found that a larger planning target volume (PTV) was a significant predictor of local failure, highlighting the importance of careful treatment planning in achieving better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential role for LINAC-based stereotactic radiosurgery for the treatment of 5 or more radioresistant melanoma brain metastases. Frakes, JM., Figura, NB., Ahmed, KA., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. Müller-Riemenschneider, F., Schwarzbach, C., Bockelbrink, A., et al.[2021]

Both stereotactic radiosurgery (SRS) and fractionated stereotactic radiosurgery (fSRS) achieved similar local control rates for vestibular schwannomas, with SRS showing 100% and fSRS showing 94.2%.

However, fSRS was associated with a significantly higher risk of toxicities (42.3% vs. 8.3% for SRS), indicating that while both treatments are effective, fSRS may pose greater safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery and fractionated stereotactic radiosurgery for vestibular schwannomas: A comparison of clinical outcomes from the RSSearch patient registry. Singh, R., Ansinelli, H., Jenkins, J., et al.[2022]

A retrospective analysis of 383 patients treated with stereotactic radiosurgery (SRS) for brain metastases showed a median survival of 9 months, indicating that SRS can be an effective treatment option.

The study found a 75% local control rate at one year, suggesting that SRS is a safe and effective method for managing brain metastases, particularly in selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linear accelerator radiosurgery in the treatment of brain metastases. Ulm, AJ., Friedman, WA., Bova, FJ., et al.[2022]

Stereotactic radiosurgery (SRS) using CyberKnife is a safe and effective treatment for elderly patients (≥65 years) with brain metastases, achieving high local control rates and maintaining a stable quality of life in 97.9% of patients.

In a study of 97 patients, SRS demonstrated a 79% overall survival rate at 3 months and a 99.2% local tumor progression-free rate at 6 months, indicating its efficacy compared to traditional whole brain radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of CyberKnife radiosurgery in elderly patients with brain metastases: a retrospective clinical evaluation. Acker, G., Hashemi, SM., Fuellhase, J., et al.[2021]

Out of 221 reported incidents related to CyberKnife™ SRS and SBRT from 2012 to 2019, the majority (205 incidents) had little to no clinical impact, indicating a high level of safety in the treatment process.

Human performance issues were the most common contributing factor (79% of incidents), with many errors occurring during pre-treatment phases, highlighting the need for improved training and protocols to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Error Pathways in CyberKnife™ Radiation Therapy. Mullins, BT., Mazur, L., Dance, M., et al.[2020]

Both gamma knife (GK) and linear accelerator (LINAC) systems provide comparable tumor control rates for vestibular schwannoma, with rates of 93% for GK and 94% for LINAC based on a meta-analysis of 39 studies involving 6516 patients.

GK may better preserve trigeminal nerve function, while LINAC is associated with a lower incidence of tinnitus, suggesting that each method has unique benefits regarding side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the long-term safety and efficacy of gamma knife and linear accelerator radiosurgery for vestibular schwannoma: A systematic review and meta-analysis. Guadix, SW., Tao, AJ., An, A., et al.[2022]

Stereotactic radiosurgery (SRS) using CyberKnife for large brain metastasis cavities (≥2 cm) showed a local failure rate of 24%, indicating it can effectively control local disease after surgery.

Patients with synchronous metastases had a higher risk of distant brain failure, suggesting that while SRS can delay the need for whole brain radiation therapy (WBRT), careful monitoring is needed for those with multiple metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial control after Cyberknife radiosurgery to the resection bed for large brain metastases. Vogel, J., Ojerholm, E., Hollander, A., et al.[2018]

Stereotactic radiosurgery (SRS) has been shown to improve patient outcomes and reduce toxicity compared to whole-brain radiation therapy (WBRT) for treating multiple brain metastases, based on three decades of research.

Current practices allow for the treatment of patients with 10 or more brain metastases using SRS alone, even with cumulative tumor volumes of up to 25 cm³, reflecting a shift in clinical approach due to advancements in cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for Multiple Brain Metastases Radiosurgery. Niranjan, A., Monaco, E., Flickinger, J., et al.[2019]

Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) have advanced significantly, necessitating updated best practices for safety and quality assurance due to their complexity and precision in delivering high doses of radiation.

A team-based approach with trained specialists and a comprehensive quality assurance program is essential for the safe and effective implementation of SRS and SBRT, emphasizing that patient safety is a collective responsibility among all stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. Das, IJ., Dawes, SL., Dominello, MM., et al.[2022]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK542166/

Stereotactic Radiosurgery (SRS) and Stereotactic Body ... - NCBI These noninvasive modalities offer effective management for a range of conditions, including brain metastases, benign brain tumors (such as ...

2. mayoclinic.org mayoclinic.org/tests-procedures/brain-stereotactic-radiosurgery/about/pac-20384679

Brain stereotactic radiosurgery This procedure delivers precise radiation therapy to treat brain tumors and other brain conditions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11909010/

Transforming Brain Tumor Care: The Global Impact of ... This study corroborates the clinical efficacy of SRS and reinforces its critical role in the multidisciplinary treatment of patients with brain tumors and ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00230-0/fulltext

Stereotactic Radiosurgery in the Management of Brain ... Stereotactic radiosurgery in the management of brain metastases: a case-based radiosurgery society practice guideline.

5. utswmed.org utswmed.org/medblog/brain-spine-tumor-treatment-technology/

Treating brain tumors with stereotactic radiosurgery Stereotactic radiosurgery is an elegant solution that allows us to treat benign and malignant brain tumors with precision, potency, and safety beyond ...

6. surgicalneurologyint.com surgicalneurologyint.com/surgicalint-articles/stereotactic-radiosurgery-versus-whole-brain-radiotherapy-for-intracranial-metastases-a-systematic-review-and-meta-analysis/

Stereotactic radiosurgery versus whole-brain radiotherapy ... SRS and WBRT exhibited similar recurrence rates and overall survival (OS) at 1 and 5 years, with WBRT being more effective in managing post-radiation LMD.