Preoperative Stereotactic Radiosurgery for Brain Metastases

Overseen By Michael Yu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Cytotoxic chemotherapies

Disqualifiers: Germ cell tumors, Lymphoma, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: 3

49 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine whether treatment with pre-operative hypofractionated stereotactic radiosurgery followed by surgery will improve time to local failure (TTLF) compared to the current standard of care.

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

The trial does not specify if you need to stop your current medications. However, if you are on cytotoxic chemotherapies, you must stop them 7 days before starting the trial. Other medications will be reviewed individually by the study team.

What data supports the effectiveness of the treatment Hypofractionated Stereotactic Radiosurgery for brain metastases?

Research shows that hypofractionated stereotactic radiosurgery (a type of focused radiation treatment given in several sessions) is effective for managing brain metastases, especially larger ones, by delivering high doses of radiation while minimizing side effects. It has been used successfully after surgery to control tumor growth and reduce the need for whole-brain radiation, which can have more side effects. ^{1 2 3 4 5}

Is hypofractionated stereotactic radiosurgery safe for treating brain metastases?

Research shows that hypofractionated stereotactic radiosurgery (a type of targeted radiation treatment) is generally safe for treating brain metastases, with most patients experiencing mild to moderate side effects. Serious side effects like radiation necrosis (damage to brain tissue from radiation) were not observed in the studies reviewed. ^{3 6 7 8 9}

How is hypofractionated stereotactic radiosurgery different from other treatments for brain metastases?

Hypofractionated stereotactic radiosurgery (HFSRT) is unique because it delivers high doses of radiation in several smaller sessions, which helps minimize side effects and is particularly useful for larger brain metastases that can't be treated with single-session radiosurgery. This approach can be safer and more effective for large tumors compared to traditional whole-brain radiation therapy. ^{1 5 6 10 11}

Research Team

Michael Yu, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for adults with certain solid tumor cancers that have spread to the brain, and are expected to live at least 3 more months. They must have one or more brain tumors suitable for surgery and not previously treated with specific radiosurgery. Participants should be able to undergo MRI scans, not be pregnant or breastfeeding, and willing to use effective contraception.

Inclusion Criteria

I am allowed to receive treatments like immunotherapy or chemotherapy as decided by my doctor.

This study permits the re-enrollment of participant who has discontinued the study due to pre-treatment failure (i.e., the participant has not been treated). If re-enrolled, participant must be re-consented

I can care for myself but may need occasional help.

Exclusion Criteria

Individuals who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

My brain cancer is near the optic nerve.

Participants with active or prior documented inherited hypersensitivity syndromes, certain collagen vascular diseases, and certain autoimmune diseases

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis

3 days

3 visits (in-person)

Surgery

Participants undergo stereotactic craniotomy for surgical resection of the index metastasis

Within 5 days following completion of fSRS

Follow-up

Participants are monitored for local control rate, rate of distant brain recurrence, and development of leptomeningeal disease

up to 12 months

Treatment Details

Interventions

• Hypofractionated Stereotactic Radiosurgery

Trial Overview The study tests if pre-operative hypofractionated stereotactic radiosurgery (a type of focused radiation therapy) followed by surgery can extend the time before a brain tumor starts growing again compared to current treatments.

Participant Groups

Group I: Hypofractionated Stereotactic Radiosurgery prior to resection Experimental Treatment 1 Intervention

Participants will be given hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis that will be resected on Days 1-3 (3 consecutive days). If there are additional non index brain metastasis, they will be treated with standard stereotactic radiosurgery at the time of fSRS. Participants will then undergo stereotactic craniotomy for surgical resection of the index metastasis within 5 days following completion of fSRS.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Findings from Research

Hypofractionated Gamma Knife radiosurgery is effective for treating large metastatic brain tumors (average volume of 18.3 cm³), achieving a local control rate of 90% and a median survival time of 16.2 months.

The treatment demonstrated low toxicity, with only 8.3% of patients experiencing grade 1 side effects and a single case of radiation necrosis, indicating it is a safe option for patients who cannot undergo surgical resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated Stereotactic Gamma Knife Radiosurgery for Large Brain Metastases: A Retrospective, Single Center Study. Kim, JW., Park, HR., Lee, JM., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic radiotherapy (hfSRT) after tumour resection of a single brain metastasis: report of a single-centre individualized treatment approach. [2021]

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

Outcomes Following Hypofractionated Stereotactic Radiotherapy in the Management of Brain Metastases. [2018]

3. France pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy following surgery for brain metastasis: Predictive factors for local control and radionecrosis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic radiotherapy for brain metastases larger than three centimeters. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiation Therapy for Large Brain Metastases. [2020]

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

Fractionated Stereotactic Gamma Knife Radiosurgery for Large Brain Metastases: A Retrospective, Single Center Study. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Radiation necrosis and therapeutic outcomes in patients treated with linear accelerator-based hypofractionated stereotactic radiosurgery for intact intracranial metastases. [2023]

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

Single-fraction versus hypofractionated stereotactic radiosurgery for medium-sized brain metastases of 2.5 to 3 cm. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Hypofractionated frameless gamma knife radiosurgery for large metastatic brain tumors. [2021]

10. Japan pubmed.ncbi.nlm.nih.gov

Retrospective analysis of hypofractionated stereotactic radiotherapy for tumors larger than 2 cm. [2020]

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

Hypofractionated radiosurgery for intact or resected brain metastases: defining the optimal dose and fractionation. [2022]