Stereotactic Radiosurgery for Brain Tumors

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Small cell lung cancer, lymphoma, 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: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation treatment called stereotactic radiosurgery to evaluate its safety and effectiveness for treating large brain tumors that have spread from other parts of the body. The treatment targets the tumor with high precision, minimizing damage to surrounding healthy tissue. It suits individuals with brain metastases larger than 2 cm but no more than 4 cm in size who have not recently undergone whole brain radiation therapy. This trial does not include those with certain types of cancer, such as small cell lung cancer, or if the tumor is located in the brainstem. Participants must attend all follow-up visits and provide written consent.

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 innovative therapy.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that stereotactic radiosurgery is safe for treating brain tumors?

Research has shown that stereotactic radiosurgery (SRS) is generally safe and well-tolerated. It uses precise radiation to target brain tumors, causing minimal damage to nearby healthy tissue. A review of 32 studies involving 1,446 patients found that SRS effectively stopped tumor growth in most cases. This well-established procedure plays an important role in treating brain tumors. While some side effects may occur, they are usually mild and temporary. Overall, SRS has a strong safety record, making it a promising option for treating brain metastases. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic Radiosurgery (SRS) is unique because it delivers highly focused radiation beams to brain tumors with precision guided by CT and MRI imaging. Unlike traditional whole-brain radiation therapy, which can affect healthy brain tissue, SRS targets only the tumor, potentially reducing side effects. Researchers are excited about SRS because it offers a non-invasive alternative to surgery, with the possibility of quicker recovery times and fewer complications. This method allows for treating tumors that are difficult to reach surgically, providing a promising option for patients with complex cases.

What evidence suggests that stereotactic radiosurgery is effective for brain tumors?

Research has shown that stereotactic radiosurgery (SRS), the treatment under study in this trial, effectively treats brain metastases, which are cancerous tumors that have spread to the brain. Studies indicate that SRS controls tumor growth in 73–96% of cases for certain cancers, such as melanoma and kidney cancer. This treatment uses focused x-rays aimed directly at the tumor, protecting the surrounding healthy brain tissue. Due to this precision, SRS serves as a valuable option for managing brain tumors and helps maintain quality of life by preserving normal brain functions. ^{3 6 7 8 9}

Who Is on the Research Team?

Samuel T. Chao, MD

Principal Investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with large brain metastases from solid tumors, excluding small cell lung cancer, lymphoma, and germ cell cancers. Participants must have lesions 2-4 cm in diameter suitable for stereotactic radiosurgery (SRS), may have had previous SRS or whole brain radiation therapy over 3 months ago, and be able to consent.

Inclusion Criteria

Patient must be able to provide written informed consent

My cancer is not small cell lung cancer, lymphoma, or germ cell.

I am receiving SRS treatment for brain cancer spread.

Exclusion Criteria

My radiation treatment plan doesn't meet specific uniformity criteria.

My cancer is not located in the brainstem.

My cancer is not small cell lung cancer, lymphoma, or germ cell.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo stereotactic radiosurgery (SRS) guided by CT and MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Visits at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, then every 4 months

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Radiosurgery

Trial Overview The study is testing the safety and optimal dose of stereotactic radiosurgery—a precise form of radiation therapy—for treating large brain metastases. It also examines how well it works by assessing quality-of-life and cognitive functions before and after treatment.

How Is the Trial Designed?

Group I: Treatment (SRS) Experimental Treatment 3 Interventions

Patients undergo SRS guided by CT and MRI.

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?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

1. 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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0305737213000947

Stereotactic radiosurgery in the treatment of brain metastases Local tumor control rates after radiosurgery of otherwise radioresistant brain metastases were 73–90% for melanoma and 83–96% for renal cell cancer. Currently, ...

3. nature.com nature.com/articles/s41467-024-47998-8

Response of treatment-naive brain metastases to ... Our results demonstrate that brain metastases ≤3 cm are not uniformly responsive to SRS and suggest that prospective studies to evaluate the effect of SRS alone

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3619246/

Stereotactic Radiosurgery and Stereotactic Body Radiation ... Results: Clinical outcomes and costs of SRS and SBRT were compared to other therapies for treatment of cancer in the brain, spine, lung, prostate, and pancreas.

5. 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.

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

Stereotactic Radiosurgery (SRS) and Stereotactic Body ... - NCBI Radiation therapy is intended to damage abnormal tissue, eg, neoplastic tumor cells, while causing minimal injury to adjacent normal tissue.

7. 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.

8. 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.

9. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2780031

Efficacy and Safety of Stereotactic Radiosurgery for ... This systematic review and meta-analysis of 32 studies comprising 1446 patients found associations with high local control (86%), high therapeutic ratio of ...