Stereotactic Radiosurgery for Brain Cancer

Overseen By Robyn Hseu

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Must not be taking: Chemotherapy, Immunotherapy, Anti-Her2

Disqualifiers: Germ cell tumor, Small cell carcinoma, Hematologic malignancy, 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: 1

166 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation therapy called frameless stereotactic radiosurgery for individuals with brain cancer that has spread from other parts of the body. Researchers aim to determine if omitting the planning target volume (PTV) margins during treatment affects the duration of cancer-free survival. Participants are divided into two groups: one receives a small margin added to the tumor, while the other does not. Suitable candidates have 1-5 brain tumors from cancer elsewhere in the body and have not received brain radiation in the last 90 days. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

You may need to stop certain medications like chemotherapy or immunotherapy 14 days before the treatment. Hormonal therapy is allowed, but specific restrictions apply to anti-Her2 therapy for breast cancer patients.

What prior data suggests that frameless stereotactic radiosurgery is safe for treating brain metastases?

Research has shown that frameless stereotactic radiosurgery (SRS) is generally safe for treating brain metastases. In one study, over 75% of patients experienced only mild side effects, indicating that most people had little to no negative effects from the treatment. Importantly, the study reported no treatment-related deaths. Another study found that SRS did not impair thinking or memory abilities, providing excellent cognitive outcomes.

These findings suggest that frameless SRS is well-tolerated and poses minimal risk to patients. However, since the current trial is in its early stages, more data is needed to confirm these results. Existing evidence remains promising for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for brain cancer?

Researchers are excited about frameless stereotactic radiosurgery for brain cancer because it offers a non-invasive and highly precise way to target tumors. Unlike traditional radiation therapy, which can affect a larger area of the brain, this method focuses radiation beams directly at the tumor with millimetric accuracy, minimizing damage to surrounding healthy tissue. The trial explores two techniques: one with a 2 mm margin and another with no margin, potentially offering even more precision. This precision could lead to fewer side effects and improved outcomes, making it a promising alternative to current treatments like whole-brain radiation therapy.

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

This trial will compare two approaches of frameless stereotactic radiosurgery for treating brain cancer. Studies have shown that this precise radiation treatment effectively addresses cancer that has spread to the brain. In one study, 64 patients with 94 brain tumors received this treatment, and researchers found it helped control tumor growth. Another study with 163 patients also reported good results, demonstrating that this method can effectively target and treat multiple tumors. While side effects like dead tissue from radiation and seizures occurred, they were uncommon. Overall, this treatment is considered a strong option for managing brain cancer, helping to control its spread and improve patient outcomes. ^{1 3 4 5 6}

Who Is on the Research Team?

Steven J. Chmura, M.D., Ph.D.

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults with certain types of cancer that has spread to the brain, showing 1-5 measurable lesions. Participants must understand and consent to the study, not be pregnant, have a reasonable life expectancy (3+ months), and good performance status. Excluded are those with specific cancers (like small cell carcinoma), brain stem metastases, recent chemotherapy or immunotherapy, prior cranial radiotherapy within 90 days or any previous stereotactic radiosurgery.

Inclusion Criteria

I am an adult with the ability to care for myself and expected to live 3 months or more.

I have a brain tumor that is 3cm or smaller, and if there are more, they also do not exceed 3cm.

Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria

I have been diagnosed with leptomeningeal disease.

My cancer has spread to critical areas of my brain or close to my optic nerves.

I have not had brain radiation in the last 90 days or any specific radiation to lesions to be treated in this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic radiosurgery with either 0 mm or 2 mm PTV margins

1 week

1 visit (in-person)

Follow-up

Participants are monitored for progression free survival and other outcomes

6 months

Regular visits as per study protocol

Extended Follow-up

Long-term monitoring for secondary outcomes such as radiation necrosis and overall survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Frameless Stereotactic Radiosurgery

Trial Overview

The study tests whether omitting treatment margins in stereotactic radiosurgery affects progression-free survival in patients with brain metastases. It's a randomized trial where participants will either receive standard treatment or an experimental approach without planning target volume margins.

How Is the Trial Designed?

Group I: Stereotactic Radiosurgery to 0 mm GTV to PTV margins Experimental Treatment 1 Intervention

Group II: Stereotactic Radiosurgery to 2 mm GTV to PTV margins Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

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.

hkmj.org

hkmj.org/abstracts/v23n6/599.htm

Frameless stereotactic radiosurgery for brain metastases

Results: In this study, 64 patients with 94 lesions were treated with a median dose of 18 Gy (range, 12-22 Gy) in a single fraction. The median ...

3.

tcr.amegroups.org

tcr.amegroups.org/article/view/2947/3457

Frameless, real-time, surface imaging-guided radiosurgery

In this study, we provide an update of our experience and clinical outcomes of 163 patients totaling 490 lesions and 45 post-operative cavities treated with SIG ...

4.

academic.oup.com

academic.oup.com/neuro-oncology/article/27/2/479/7787241

Results of the CYBER-SPACE randomized phase 2 trial

Most common grade 3 TRAE were radionecrosis (n = 9, 4.6% of overall cohort), seizures (n = 7, 3.6%), and focal neurological deficits (n = 7, 3.6%).

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12540553/

Frameless linac-based radiosurgery for benign intracranial ...

Nearly half (45.1%) were treated in a single fraction (12–22 Gy) versus 54.9% with fractionated SRS (24–35 Gy). Mean RTOG CI and Paddick GI were ...

6.

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 ...