Radiation Therapy for Brain Cancer

Overseen By David Shultz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Prior cranial radiotherapy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1-2 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of brain radiation affect the brain and thinking skills over time. It focuses on patients with brain metastases, which are cancer cells that have spread to the brain from other parts of the body. Participants will receive either stereotactic radiosurgery (SRS) or whole brain radiotherapy (WBRT) to assess the impact of each treatment on cognitive function. This trial suits individuals with MRI-confirmed brain metastases who have not received previous brain radiation. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking 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.

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

Research has shown that stereotactic radiosurgery (SRS) is generally safe and well-tolerated for treating cancer that has spread to the brain. One study found that SRS did not significantly harm brain function, resulting in good cognitive outcomes. Another study demonstrated that SRS effectively targeted tumors, achieving a high success rate of 97.6% after one year without damaging nearby brain tissue.

In contrast, whole-brain radiotherapy (WBRT) presents some drawbacks. Research indicates that WBRT can lead to worse brain function over time. Specifically, patients who received WBRT experienced a noticeable decline in brain function after 12 months. This is important to consider, especially if maintaining brain function is a priority.

Overall, both treatments have their advantages and disadvantages. SRS generally preserves brain function better than WBRT, but both are established treatments for cancer that has spread to the brain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in this trial because they explore how different types of brain radiation might affect cerebral blood flow and neurocognitive function. Stereotactic radiosurgery (SRS) is unique because it delivers a high dose of radiation precisely to a small area, targeting brain tumors while sparing healthy tissue. This precision is what sets it apart from whole brain radiotherapy (WBRT), which treats the entire brain and is typically used when there are multiple lesions. Understanding how these approaches impact the brain could lead to more tailored and effective treatments for patients with brain metastases.

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

This trial will compare stereotactic radiosurgery (SRS) and whole brain radiotherapy (WBRT) for treating brain metastases. Studies have shown that SRS effectively treats cancer that has spread to the brain, especially in patients with a small number of tumors, as it delivers high doses of radiation directly to the tumor while protecting surrounding healthy tissue. Participants in Arm A of this trial will receive SRS.

Participants in Arm B will receive WBRT. Research has indicated that more than half of the patients receiving WBRT reported pain relief within three months of treatment. However, evidence also shows that WBRT can lead to memory and thinking problems over time, with these issues worsening 12 months after treatment. While both treatments have their benefits, SRS is often preferred for patients with fewer tumors because it is more precise and may lead to better mental function outcomes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with brain metastases will be included in this study. Patients with known malignancies but without brain metastases, or patients with primary brain tumors are not eligible for enrollment.

MRI confirmed 1-10 lesions. Each lesion must not be intended for resection.

No prior radiation therapy for brain tumours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Assessment

Neurocognitive function is assessed before radiation treatment

1 week

1 visit (in-person)

Treatment

Participants receive either SRS or WBRT for brain metastases

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for neurocognitive function and other outcomes post-treatment

24 months

Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• SRS
• WBRT

How Is the Trial Designed?

Group I: Arm B. Experimental Treatment 1 Intervention

Patients in Arm B will be treated with whole brain radiotherapy, due to the number of lesions in their brain.

Group II: Arm A Experimental Treatment 1 Intervention

Patients in Arm A will be treated with stereotactic radiosurgery (SRS) which is a modern method of treating brain lesions that delivers a high amount of radiation to a small volume of the brain affected by a tumour; and is the standard of care for patients with a limited number of brain metastases.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11049204/

Prognosis versus Actual Outcomes in Stereotactic ... This study aims to evaluate the clinical outcome of stereotactic radiosurgery as the sole treatment for brain metastases and to assess prognostic factors ...

2. 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

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-11452-7

Overall survival following stereotactic radiosurgery for ten or ... Patients with 10 or more brain metastases treated with stereotactic radiosurgery can have prolonged survival outcomes.

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590139725000067

Stereotactic radiosurgery alone for patients with 16 or more ... A recent meta-analysis of studies of patients treated with SRS-alone showed significantly worse OS (HR = 1.10, p < 0.001) in patients with <10 vs ≥ 10 brain ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38799108/

Safety and Feasibility of Stereotactic Radiosurgery for ... We present here one of the largest studies evaluating SRS for patients with ≥15 BMs. SRS was safe, had favorable cognitive outcomes, and had comparable ...

7. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00072-1/fulltext

Safety and Feasibility of Stereotactic Radiosurgery for ... Patients who did not receive prior brain RT had a longer median survival (7.4 months vs 4.6 months, P = .034). The 12m local control was 97.6%, and the ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625028032

Stereotactic Radiosurgery for 15 or More Brain Metastases ... The mean summed dose to the whole brain after all SRS courses was 5.28 Gy. Median and 1-year OS was 27.8 months and 63.2%, respectively. 1-year FFN was 87.3%.

9. neurology.org neurology.org/doi/10.1212/WNL.0000000000205892

A Systematic Review and Meta-analysis (P4-5.011) SRS has been associated with better survival and local tumor control. It is a safer procedure that enhances short-term quality of life and preserves cognitive ...

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

Efficacy and Safety of Stereotactic Radiosurgery for ... Results of this systematic review and meta-analysis demonstrate that SRS for BSM has been associated with effectiveness, safety, and improved ...