Stereotactic Radiosurgery for Brain Metastasis

Recruiting at 239 trial locations

Overseen By Paul D. Brown, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

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

242 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two radiation treatments for patients with brain cancer that has spread and been surgically removed. One treatment uses a single session of radiation, while the other uses several sessions. The goal is to see which method is more effective and has fewer side effects.

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.

What data supports the effectiveness of the treatment Stereotactic Radiosurgery for Brain Metastasis?

Stereotactic radiosurgery is effective in controlling brain metastasis, especially for small solitary tumors, with low side effects and high success rates. It has been shown to improve survival in patients with brain metastases from breast cancer, particularly those with small lesions and good health status, and can treat tumors in hard-to-reach areas of the brain. ^{1 2 3 4 5}

Is stereotactic radiosurgery safe for treating brain metastases?

Stereotactic radiosurgery (SRS) is generally considered safe for treating brain metastases, but it can have side effects like brain necrosis (damage to brain tissue). Fractionated SRS (fSRS), which spreads the treatment over several sessions, may reduce the risk of this side effect compared to single-session SRS, especially for larger brain metastases. ^{6 7 8 9 10}

How does stereotactic radiosurgery differ from other treatments for brain metastasis?

Stereotactic radiosurgery (SRS) is unique because it delivers highly precise radiation to brain metastases in either a single session or a few sessions, sparing healthy brain tissue. This approach is particularly effective for small, well-defined tumors and offers a non-invasive alternative to surgery with fewer side effects compared to whole brain radiotherapy. ^{5 11 12 13 14}

Research Team

Paul D. Brown, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Fractionated radiosurgery for brain metastases in 43 patients with breast carcinoma. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Radiosurgery for the treatment of brain metastases. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The results of resection after stereotactic radiosurgery for brain metastases. [2010]

4. France pubmed.ncbi.nlm.nih.gov

[Stereotactic radiotherapy for brain metastasis]. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Radiosurgery: its role in brain metastasis management. [2005]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse radiation effect and freedom from progression following repeat stereotactic radiosurgery for brain metastases. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Fractionated stereotactic radiosurgery for large brain metastases. [2018]

8. England pubmed.ncbi.nlm.nih.gov

SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Single Fraction and Multi Fraction Radiosurgery on the Gamma Knife ICON: A Single Institution Review. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. [2021]

11. England pubmed.ncbi.nlm.nih.gov

New developments in intracranial stereotactic radiotherapy for metastases. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Radiobiology of brain metastasis: applications in stereotactic radiosurgery. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for brain metastases from breast cancer. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery for Multiple Brain Metastases. [2020]