Radiosurgery vs Radiotherapy for Brain Cancer

Overseen By HCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Prior cranial radiotherapy, Leptomeningeal disease, Inability to undergo MRI, 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

Duration: 3-5 days for FSRT or approximately 30 days for SSRS

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of radiation treatments to determine which is more effective for individuals with large brain tumors that have metastasized. It compares staged stereotactic radiosurgery (SSRS), which delivers a high dose of radiation in a few treatments, to fractionated stereotactic radiotherapy (FSRT), which spreads the dose over more sessions. The goal is to identify which method is safer and more effective in shrinking tumors. Suitable participants have large brain metastases between 2 and 5 cm wide and have received a non-brain cancer diagnosis within the last three years. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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. However, you cannot have planned chemotherapy or immunotherapy within 3 days before, on the day of, or 3 days after the radiosurgery.

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

Studies have shown that Fractionated Stereotactic Radiotherapy (FSRT) is generally well-tolerated for treating brain metastases. Research indicates it effectively controls tumor growth with few serious side effects. Patients find the treatment manageable, and it is designed to minimize the risk of major complications.

For Staged Stereotactic Radiosurgery (SSRS), research suggests it is a safe option for treating brain tumors. Recent data show that SSRS can effectively treat brain metastases with few negative effects. This method is known for its high precision, which helps protect healthy brain tissue.

Both FSRT and SSRS have been successfully used in patients, demonstrating they are well-tolerated treatments with low risks of severe side effects. However, like any medical treatment, some risks exist, and discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments being studied for brain cancer because they offer innovative ways to target tumors with precision. Fractionated Stereotactic Radiotherapy (FSRT) is unique because it delivers radiation in multiple small doses over a few days, which can minimize damage to healthy brain tissue. Staged Stereotactic Radiosurgery (SSRS), on the other hand, treats large brain metastases in just two doses spaced a month apart, allowing for a high dose of radiation that is precisely focused, potentially leading to more effective results. Both methods aim to improve the accuracy and effectiveness of radiation therapy compared to traditional whole-brain radiotherapy, which can affect more of the brain and take longer to complete.

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

This trial will compare Fractionated Stereotactic Radiotherapy (FSRT) with Staged Stereotactic Radiosurgery (SSRS) for treating brain metastases. Research has shown that FSRT effectively controls the disease, with some studies indicating it can prevent cancer from spreading in the brain for about 12.4 months. It is also considered safe. Meanwhile, SSRS has an 83% chance of controlling brain metastases at 12 months. One study found that SSRS significantly reduces tumors larger than 2 cm, with high success rates at 3 and 6 months. Both treatments offer promising options for managing large brain metastases in this trial. ^{2 6 7 8 9}

Who Is on the Research Team?

Charlotte Rivers, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

The BIGSHOT trial is for patients with large brain metastases, specifically tumors between 2 and 5 cm. It's designed to compare two radiation treatments to see which works better for these kinds of brain tumors.

Inclusion Criteria

Patient must be willing to comply with all study procedures and available for the duration of the study

A negative urine or serum pregnancy test (in persons of childbearing potential) within 7 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal

Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy

Exclusion Criteria

Inability to undergo MRI with contrast

I have had brain radiation therapy before.

My cancer has spread to the lining of my brain and spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Fractionated Stereotactic Radiotherapy (FSRT) or Staged Stereotactic Radiosurgery (SSRS) for large brain metastases

3-5 days for FSRT or approximately 30 days for SSRS

3 visits for FSRT or 2 visits for SSRS

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of local control and radiation necrosis

Up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Fractionated Stereotactic Radiotherapy (FSRT)
• Staged Stereotactic Radiosurgery (SSRS)

Trial Overview This phase II trial tests Staged Stereotactic Radiosurgery (SSRS) against Fractionated Stereotactic Radiotherapy (FSRT). Both are standard care options for treating large brain metastases, and the study will assess their effectiveness and safety.

How Is the Trial Designed?

Group I: Staged Stereotactic Radiosurgery (SSRS) Experimental Treatment 1 Intervention

Patient will be scheduled for treatment with SSRS within one week of randomization. The large brain metastasis (or metastases) will be treated to a dose of 24-30 Gy in two fractions. Interval between the two fractions will be 30 days (+/- 10 days). MRI brain for planning purposes will be obtained either on the day of each treatment, or within 7 days prior to each treatment. Individual dosing for each fraction will be determined by the treating radiation oncologist, but total dose must equal 24-30 Gy. Any additional smaller metastases will be treated in a single fraction concurrently. Fixation for treatment will be either in a surgical headframe or mask.

Group II: Fractionated Stereotactic Radiotherapy (FSRT) Experimental Treatment 1 Intervention

Patient will be scheduled for treatment with FSRT within one week of randomization. FSRT will be performed with mask fixation. Fractionation will be 27 Gy in 3 daily fractions. The 3 daily fractions must be completed over a period of 3-5 days. MRI for planning purposes must be completed within 7 days prior to delivery of first fraction. Any additional smaller metastases will be treated in a single fraction concurrently.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10201793/

Fractionated stereotactic radiotherapy of brain metastases Conclusions. FSRT in 6 fractions of 5 Gy seems to be an effective treatment with an acceptable local control for patients with brain metastases ...

2. ar.iiarjournals.org ar.iiarjournals.org/content/43/6/2757

Treatment Outcomes After Higher-dose Fractionated ... Higher-dose FSRT appears feasible and effective in patients with 1-4 brain metastases. BED 63-66.7 Gy 12 may not improve LC and OS but may increase RN risk.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624013981

Biological Effective Dose-Based Fractionated Stereotactic ... The study validates the hypothesis, showing that FSRT with a consistent BED can achieve adequate local control and favorable toxicity profiles for NSCLC brain ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1471004/full

Analysis of linear accelerator-based fractionated ... Results: Results as of December 2023 showed median intracranial progression-free survival (iPFS) at 12.4 months, with median overall survival (OS) not reached ...

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

A Case-Based Radiosurgery Society Practice Guideline Brain metastases are common among adult patients with solid malignancies and are increasingly being treated with stereotactic radiosurgery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5707424/

Fractionated stereotactic radiation therapy for intact brain ... FSRT for brain metastases appears to demonstrate a high rate of local control with minimal risk of severe toxicity.

7. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02277-6

Fractionated stereotactic radiotherapy of brain metastases FSRT in 6 fractions of 5 Gy seems to be an effective treatment with an acceptable local control for patients with brain metastases.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424000721;

Safety and Feasibility of Stereotactic Radiosurgery for ... We found that SRS was safe, had excellent subjective cognitive outcomes, and had comparable survival outcomes to contemporary studies evaluating WBRT in this ...

9. thelancet.com thelancet.com/pdfs/journals/eclinm/PIIS2589-5370(25)00121-X.pdf

guided fractionated stereotactic radiotherapy for brain ... The primary endpoint was 1-year intracranial progression-free survival (IPFS); secondary endpoints included objective response rate (ORR), 1- ...