Radiosurgery for Brain Cancer

Recruiting at 3 trial locations

Overseen By Wenyin Shi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Disqualifiers: Glioma, Brain tumor, Chemotherapy, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 week

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of targeted radiation treatments, stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT), affect brain function in individuals with multiple brain tumors from other cancers. The researchers aim to determine if SRS can better preserve neurological function compared to SBRT. Candidates for this trial typically have between 1 to 10 brain tumors from a solid tumor cancer, excluding small cell lung cancer or germ cell tumors, with no more than two tumors being large (3 cm or more). Participants must also be able to complete mental function tests as part of the study. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve treatment options for brain tumors.

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, it mentions that planned chemotherapy during radiosurgery is not allowed, which might imply some restrictions on certain treatments.

What prior data suggests that stereotactic radiosurgery and stereotactic body radiation therapy are safe for treating brain metastases?

In a previous study, standard doses of stereotactic body radiation therapy (SBRT) were safe for all 35 patients, with no serious side effects reported. Another study found that a similar treatment, stereotactic radiosurgery (SRS), plays a crucial role in treating brain tumors while avoiding the risks of traditional surgery. Both SBRT and SRS have been safely used for many years to treat brain conditions. These methods are generally well-tolerated and effective in managing cancer that has spread to the brain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Body Radiation Therapy (SBRT) and Stereotactic Radiosurgery (SRS) for brain cancer because these techniques offer a highly precise way to target tumors. Unlike traditional radiation therapy, which can affect a larger area of healthy brain tissue, SBRT and SRS focus radiation beams directly on the tumor, minimizing damage to surrounding areas. This precision not only reduces side effects but also allows for higher doses of radiation to be delivered in fewer sessions, potentially improving outcomes and convenience for patients. With neurocognitive testing included, researchers hope to better understand the cognitive effects of these treatments over time.

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

Research has shown that stereotactic radiosurgery (SRS), one of the treatments in this trial, effectively treats cancer that has spread to the brain. Clinical studies reported that about 85% of patients experienced good tumor control with SRS. For certain cancers like melanoma and kidney cancer, the success rate for controlling brain tumors ranges from 73-90%.

Stereotactic body radiation therapy (SBRT), another treatment option in this trial, has also proven effective, with success rates of 70-80% in controlling tumors within 12-18 months. Both treatments are precise, targeting tumors while sparing healthy tissue. This precision reduces damage to the brain and helps maintain brain function. ^{2 6 7 8 9}

Who Is on the Research Team?

Wenyin Shi

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults with solid tumor cancers, except SCLC and germ cell tumors, who have 1-10 brain metastases. They must be in good enough health to follow the study plan and complete cognitive tests. Pregnant women or those planning chemotherapy during radiosurgery are excluded.

Inclusion Criteria

I can care for myself but may need occasional help.

I have a confirmed solid tumor cancer, not including small cell lung or germ cell tumors.

My kidney function is within the required range.

Exclusion Criteria

I have had more than one seizure per week despite taking seizure medication.

I have been diagnosed with a grade II-IV primary brain tumor.

I had brain surgery less than 14 days ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline

1 week

1-3 visits (in-person)

Follow-up

Participants are monitored for neurocognitive function and other outcomes at 2, 4, 6, 8, 10, and 12 months after treatment

12 months

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Assessment
• Stereotactic Body Radiation Therapy
• Stereotactic Radiosurgery

Trial Overview The trial is testing how stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT) affects neurological function in patients with multiple brain metastases. It aims to determine if SRS better preserves neurocognition than SBRT.

How Is the Trial Designed?

Group I: Supportive care (SRS/SBRT, neurocognitive testing) Experimental Treatment 4 Interventions

Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Recruited

10,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Stereotactic ablative body radiosurgery (SABR) and stereotactic body radiation therapy (SBRT) deliver high doses of radiation precisely to tumors, which may improve treatment outcomes compared to conventional low-dose radiation therapy (1.8-2Gy).

These advanced techniques not only enhance tumor ablation but also interact beneficially with biological and immunologic therapies, while incorporating methods to protect normal tissues, making them suitable for various types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). Folkert, MR., Timmerman, RD.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

In a study of 73 patients with metastatic lung tumors treated using the CyberKnife system, stereotactic ablative body radiotherapy (SABR) demonstrated high effectiveness, achieving a 2-year local control rate of 89.1% and an overall survival rate of 71.3%.

The treatment was associated with acceptable toxicity levels, with only two cases of grade 2 or higher radiation pneumonitis, indicating that SABR with a central high dose is a safe option for managing metastatic lung tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2023]

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.

The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. David, S., Tan, J., Savas, P., et al.[2020]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

Stereotactic radiosurgery (SRS) using CyberKnife for large brain metastasis cavities (≥2 cm) showed a local failure rate of 24%, indicating it can effectively control local disease after surgery.

Patients with synchronous metastases had a higher risk of distant brain failure, suggesting that while SRS can delay the need for whole brain radiation therapy (WBRT), careful monitoring is needed for those with multiple metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial control after Cyberknife radiosurgery to the resection bed for large brain metastases. Vogel, J., Ojerholm, E., Hollander, A., et al.[2018]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3619246/

Stereotactic Radiosurgery and Stereotactic Body Radiation ... Results: Clinical outcomes and costs of SRS and SBRT were compared to other therapies for treatment of cancer in the brain, spine, lung, prostate, and pancreas.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993982/

Clinical outcomes and efficacy of stereotactic body radiation ... While outcomes remain excellent for leukemias (5 year OS:87%) and lymphomas (5 year OS:94%), patients with certain solid tumors including malignant bone tumors, ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2013.00077/pdf

Stereotactic radiosurgery and stereotactic body radiation ... Results: Clinical outcomes and costs of SRS and SBRT were compared to other therapies for treatment of cancer in the brain, spine, lung, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405630823000095

Is single fraction the future of stereotactic body radiation ... LC rates at 12–18 months were 70–80 % overall, without dose-limiting toxicity. In the series by Goodman et al., two patients with tumors located in the porta ...

5. hca.wa.gov hca.wa.gov/assets/program/SRS-SBRT-update-lit-search-20170125.pdf

An Evidence Update There is some additional evidence to support the conclusion that SRS is an effective treatment for brain cancer. The most recent systematic review is an update ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5658895/

Quality and safety in stereotactic radiosurgery and stereotactic ... By most accounts, stereotactic radiosurgery and stereotactic body radiation therapy are safe and effective. SRS has been used for decades in the treatment of ...

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778658

Evaluation of Safety of Stereotactic Body Radiotherapy for ... Standard doses were safe in all 35 evaluable patients, with a median of 3 metastases; there were no protocol-defined dose-limiting toxicities, ...

8. oncodaily.com oncodaily.com/oncolibrary/radiotherapy/stereotactic-radiotherapy-success

Success Rate and Survival After Stereotactic Radiotherapy The authors concluded that SABR appears relatively safe and provides clinically acceptable control and survival rates. In a 2024 study published ...

9. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2773455

Safety and Survival Rates Associated With Ablative ... The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.