Stereotactic Radiosurgery for Brain Metastasis

Not currently recruiting at 245 trial locations

Overseen By Paul D. Brown, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Disqualifiers: Whole brain radiation, Germ cell tumor, Lymphoma, Leptomeningeal metastasis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 31

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two approaches to treating brain tumors that have spread from other parts of the body. Single Fraction Stereotactic Radiosurgery involves a single, high dose of radiation, while Fractionated Stereotactic Radiosurgery delivers several smaller doses over a few days. The researchers aim to determine which method is more effective and causes fewer side effects. Individuals who have had surgery to remove a brain metastasis and have up to three small, remaining tumors might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both single-session and multiple-session stereotactic radiosurgery are generally well-tolerated by patients. Studies on multiple-session stereotactic radiosurgery indicate it effectively controls tumors while protecting nearby brain areas from excessive radiation, reducing harm to healthy tissue.

For single-session stereotactic radiosurgery, research indicates it is safe even for patients with several brain tumors, showing positive results for cognitive skills and survival rates.

In both cases, the risk of serious side effects remains low, as these treatments precisely target the tumor with radiation. This precision minimizes damage to surrounding healthy tissue, significantly benefiting patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about stereotactic radiosurgery (SRS) for brain metastasis because it offers precision targeting of tumors. Unlike traditional whole-brain radiation therapy, which can affect healthy brain tissue, SRS focuses radiation directly on cancer cells, potentially reducing side effects. The trial investigates two approaches: Single Fraction SRS (SSRS) delivers a high dose in one session, while Fractionated SRS (FSRS) spreads the dose over several sessions, which might be gentler on surrounding healthy tissue. This flexibility and precision make SRS a promising option for more effective and patient-friendly treatment.

What evidence suggests that this trial's treatments could be effective for brain metastasis?

This trial will compare two treatments: fractionated stereotactic radiosurgery (FSRS) and single fraction stereotactic radiosurgery (SSRS). Studies have shown that FSRS might control brain tumors better than SSRS. In one study, patients who received FSRS had better overall health and experienced fewer side effects, such as tissue damage. Another study found that FSRS lowered the risk of side effects compared to SSRS. However, SSRS also proves effective, with studies showing it can control brain tumors in up to 86% of patients after one year. Both treatments offer advantages, and ongoing research aims to determine the best option for patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Paul D. Brown, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with up to three brain metastases from cancer that has spread, but not from germ cell tumors, small cell carcinoma, or lymphoma. Participants must have had one tumor surgically removed within the last 30 days and can't have had whole brain radiation before. They should be able to complete questionnaires in English, Spanish, or French and undergo MRI scans.

Inclusion Criteria

My cancer may have spread to my brain from another part of my body.

My surgery area is smaller than 5.0 cm and fully removed, confirmed by a recent MRI.

My cancer has spread to the protective covering of the brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo stereotactic radiosurgery, either single fraction (SSRS) or fractionated (FSRS) over 3 or 5 daily sessions

1 week

1-5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Follow-up at 30 days, 3, 6, 9, 12, 16, and 24 months, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fractionated Stereotactic Radiosurgery
• Single Fraction Stereotactic Radiosurgery

Trial Overview The study compares single-dose stereotactic radiosurgery (a high dose of targeted radiation) with fractionated stereotactic radiosurgery (smaller doses over time) for treating resected brain metastasis. It aims to determine which method is more effective and less harmful to healthy tissue.

How Is the Trial Designed?

Group I: Arm II (FSRS) Experimental Treatment 3 Interventions

Patients undergo FSRS over 3 or 5 daily sessions.

Group II: Arm I (SSRS) Active Control 3 Interventions

Patients undergo SSRS over 1 session.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Stereotactic radiosurgery for brain metastases from breast cancer showed a high tumor control rate of 93% and a median survival of 13 months post-treatment, indicating its efficacy as a treatment option.

The absence of multiple brain metastases was the only significant factor associated with longer survival, while the treatment had a low complication rate, with only a few cases of radiation-induced edema that did not require further surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for brain metastases from breast cancer. Firlik, KS., Kondziolka, D., Flickinger, JC., et al.[2019]

Fractionated stereotactic radiosurgery (fSRS) is a safe and effective treatment option for patients with larger brain metastases (tumor volume >2.061 cm3) who are not suitable for single fraction stereotactic radiosurgery (SRS).

Delays in treatment can negatively impact local control of the tumors, with a significant difference in local control rates observed based on whether treatment occurred within 10 days of planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Single Fraction and Multi Fraction Radiosurgery on the Gamma Knife ICON: A Single Institution Review. Loftus, JP., Shepard, M., Liang, Y., et al.[2023]

Stereotactic radiosurgery (SRS) is increasingly being used for patients with multiple brain metastases, showing similar survival rates for those with more than 4 lesions compared to those with 4 or fewer, while maintaining neurocognitive function and quality of life.

While whole-brain radiation therapy (WBRT) has been the traditional treatment for multiple brain metastases, it is associated with significant cognitive decline and does not significantly improve overall survival, making SRS a more favorable option for selected patients, especially those with a better prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery for Multiple Brain Metastases. Kraft, J., Zindler, J., Minniti, G., et al.[2020]

Stereotactic radiosurgery (SRS) is an effective treatment for patients with brain metastases, particularly prolonging survival for those with a single metastasis and maintaining functional independence for patients with up to three metastases.

As SRS technology becomes more widely used, careful patient selection and treatment planning are essential to maximize its benefits and integrate it safely with other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in intracranial stereotactic radiotherapy for metastases. Pinkham, MB., Whitfield, GA., Brada, M.[2022]

Stereotactic radiosurgery is highly effective in managing both newly diagnosed and recurrent brain metastases, making it a preferred treatment option.

This method is particularly beneficial for patients with small, solitary brain metastases due to its low risk of complications, high effectiveness, and cost efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosurgery: its role in brain metastasis management. Flickinger, JC., Lunsford, LD., Somaza, S., et al.[2005]

Stereotactic radiosurgery effectively targets small, well-defined brain metastases while protecting surrounding healthy brain tissue, making it a suitable treatment option for these types of tumors.

Recent advancements in radiosurgical planning, including improved blocking patterns and beam shaping, have enhanced the precision of radiation delivery, reducing the risk of radiation toxicity to the central nervous system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiobiology of brain metastasis: applications in stereotactic radiosurgery. Jagannathan, J., Sherman, JH., Mehta, GU., et al.[2019]

In a study of 58 patients who underwent resection of brain metastases after stereotactic radiosurgery (SRS), the median survival after resection was 7.7 months, with survival rates of 65%, 30%, and 16% at 6, 12, and 24 months, respectively.

Factors such as preoperative classification, performance status, systemic disease status, and the time interval between SRS and resection were found to significantly influence patient survival, with better outcomes observed in patients with delayed local progression after SRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The results of resection after stereotactic radiosurgery for brain metastases. Kano, H., Kondziolka, D., Zorro, O., et al.[2010]

Fractionated stereotactic radiosurgery (SRS) for large brain metastases (over 3 cm) is both feasible and safe, with no reported acute or late complications in a study of 36 patients.

The treatment showed improved local control rates, with 73% progression-free survival at 6 months and 63% at 12 months, suggesting it may be more effective than single fraction SRS for these larger tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated stereotactic radiosurgery for large brain metastases. Wegner, RE., Leeman, JE., Kabolizadeh, P., et al.[2018]

Moderately dosed stereotactic radiosurgery (SRS) for one to four brain metastases showed a median overall survival of 7.5 months, with high local brain control rates of 87% at 6 months and 79% at 12 months, indicating its efficacy in treating limited brain metastases.

The study suggests that initial SRS alone can be a safe treatment option, as only 22% of patients required additional whole-brain radiotherapy, and significant predictors of survival included the time between the primary diagnosis and brain metastases, as well as the volume of the treated metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. Meisner, J., Meyer, A., Polivka, B., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4630352/

Efficacy and Safety of Fractionated Stereotactic Radiosurgery ... Patient performance status and preoperative focal neurologic deficits improved in 20 of 35 (57.1%) and 12 of 17 patients (70.6%), respectively. Radiation ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875022002455

Clinical Outcomes and Prognostic Factors of Fractionated ... Overall, 116 lesions in 105 patients were evaluated. The performance status was 0–1, 2–4, and unknown for 86, 28, and 2 patients, respectively.

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

Stereotactic Radiosurgery in the Management of Brain ... Initially, the RTOG 9508 trial demonstrated superior local control with WBRT plus SRS compared with WBRT alone in patients with 1 to 3 brain ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-10761-1

phase II randomized trial to compare stereotactic radiosurgery ... Several retrospective studies have shown improved local control and less radionecrosis when using fSRS compared with single fraction SRS, ...

5. 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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468168/

Hypo-Fractionated Stereotactic Radiosurgery for the ... This technique maintains high tumor control while minimizing radiation toxicity to nearby brain structures. This review summarizes the current ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875023010914

Comparison of Staged Stereotactic Radiosurgery and ... SSRS and FSRT were found to be comparable for treating brain metastases >2 cm not previously irradiated. Given the paucity of such studies, trials directly ...

8. appliedradiationoncology.com appliedradiationoncology.com/articles/stereotactic-radiosurgery-for-brain-metastases-review-of-existing-data-and-future-directions

Stereotactic Radiosurgery for Brain Metastases: Review of ... Outcome evaluation of patients treated with fractionated Gamma Knife radiosurgery for large (> 3 cm) brain metastases: a dose-escalation study.