Stereotactic Radiation for Brain Cancer

Overseen By Ivy B Ricca, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ayal A. Aizer, MD

Disqualifiers: End stage renal disease, Leptomeningeal disease, Pregnant, 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: 13

Duration: 1 day per treatment session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether accelerating radiation planning and treatment can improve outcomes for people with brain cancer. The focus is on using precise stereotactic radiation, a targeted form of radiation therapy, to treat brain metastases more effectively. Participants will be randomly assigned to receive treatment with either a 0mm or 1mm margin, determining how much extra tissue around the tumor is targeted. Those with a rapidly growing brain tumor, near swelling, or close to recent surgery might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in brain cancer treatment.

Do I need to stop 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 study team or your doctor.

What prior data suggests that this radiation technique is safe for brain cancer treatment?

Research has shown that linear accelerator-based stereotactic radiation is generally safe for treating cancer that has spread to the brain. Studies have found that this treatment rarely causes serious side effects, so most people do not experience major negative reactions. One study found it to be as safe and effective as other brain radiation treatments, with added benefits for brain function. This treatment has successfully controlled tumor growth and reduced symptoms in patients with brain tumors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about stereotactic radiation for brain cancer because it offers a highly precise treatment option. Unlike traditional radiation therapy, which can affect both cancerous and healthy tissue, this method uses a linear accelerator to deliver focused radiation beams with millimeter precision. This trial specifically investigates different uncertainty margins (0mm and 1mm PTV), which could potentially allow for even more targeted treatment, minimizing damage to surrounding healthy brain tissue. By fine-tuning the precision of radiation delivery, there is hope for improved outcomes and reduced side effects for patients.

What evidence suggests that same-day stereotactic radiation planning and treatment could be effective for brain cancer?

This trial will compare different approaches to stereotactic radiation for brain cancer. Research has shown that this specialized radiation treatment can be very effective. Studies have found it to be safe, with a low risk of serious side effects. In one study, many patients did not experience new tumor growth for about 12.4 months. Another study confirmed that this treatment helps control tumor growth and improves symptoms for patients with brain tumors. Overall, this treatment has been linked to longer survival in patients, making it a promising option. ^{1 2 4 6 7}

Who Is on the Research Team?

Ayal A Aizer, MD, MHS

Principal Investigator

Dana-Farber/Brigham and Women's Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed solid malignancy and at least one brain metastasis. They must have a Karnofsky performance status of at least 60, an estimated survival of 3-6 months, and be able to consent. It excludes those who can't tolerate MRI or gadolinium, have widespread leptomeningeal disease, are pregnant/breastfeeding, or have end stage renal disease.

Inclusion Criteria

Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI

I have a confirmed solid tumor with at least one brain metastasis.

I am 18 years old or older.

Exclusion Criteria

Participants who cannot tolerate a brain MRI

Patients who cannot receive gadolinium

I have a confirmed widespread leptomeningeal disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive adaptively designed stereotactic radiation with same-day planning and treatment

1 day per treatment session

Multiple visits (in-person) for each treatment session

Follow-up

Participants are monitored for safety, effectiveness, and development of new symptoms or disease progression

12 months

Regular visits (in-person and virtual) over 12 months

Long-term follow-up

Participants are assessed for overall survival, neurocognitive function, and quality of life

Estimated 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Linear accelerator-based stereotactic radiation

Trial Overview The study tests same-day radiation planning and treatment for brain metastases using stereotactic radiation with either a very tight (0mm) or small (1mm) margin around the tumor. The goal is to keep tumors within high-dose radiation fields by reducing time between mapping and treating.

How Is the Trial Designed?

Group I: 0mm PTV Experimental Treatment 1 Intervention

0mm uncertainty margin

Group II: 1mm PTV Active Control 1 Intervention

1mm uncertainty margin

Who Is Running the Clinical Trial?

Ayal A. Aizer, MD

Lead Sponsor

Varian, a Siemens Healthineers Company

Industry Sponsor

Trials

35

Recruited

7,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10173492/

Linear accelerator-based stereotactic radiotherapy for brain ... SRT using a linear accelerator for brain metastases, including multiple and large lesions, is safe, with a low incidence of ISEs.

2. 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 ...

3. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02360-y

Dose-effect relationship of linear accelerator based ... The purpose of this study is to reveal the dose-effect relationship of linear accelerator (LINAC)-based stereotactic radiotherapy (SRT) in patients with brain ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024000810

Clinical Results and Hematologic Predictors of Linear ... Six-month, 1-year, and 2-year survival in EPs was 58.3%, 43.1%, and 27.7%, respectively. For EPs, prognostic factors associated with prolonged survival included ...

5. journals.lww.com journals.lww.com/tcmj/fulltext/2022/34040/clinical_outcomes_of_benign_brain_tumors_treated.17.aspx

Clinical outcomes of benign brain tumors treated with... Our results suggested that LINAC-based SRS effectively controls tumor growth and tumor-related neurological symptoms for patients with benign brain tumors.

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

Safety and Feasibility of Stereotactic Radiosurgery for ... SRS was safe, had favorable cognitive outcomes, and had comparable survival outcomes to contemporary studies evaluating WBRT in this population. Treatment-naïve ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452109423002300

Stereotactic Radiosurgery in the Management of Brain ... Brain metastases are common among adult patients with solid malignancies and are increasingly being treated with stereotactic radiosurgery (SRS).