Radiosurgery for Brain Tumor

Recruiting in Palo Alto (17 mi)

Overseen by Erin Murphy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Unfit for surgery, Prior whole brain radiotherapy, MRI contraindication, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the treatment Radiosurgery for Brain Tumor?

Research shows that stereotactic radiosurgery (SRS), including Gamma Knife radiosurgery, is effective for treating brain metastases and can improve survival when used with or instead of whole-brain radiation therapy. It is also used for other brain conditions like meningiomas and pituitary adenomas, suggesting its effectiveness in targeting specific brain areas with high precision. ^{1 2 3 4 5}

Is radiosurgery generally safe for treating brain tumors?

Radiosurgery, including Stereotactic Radiosurgery (SRS) and Gamma Knife Radiosurgery, is generally considered safe for treating various brain conditions, though there are rare reports of it being associated with new malignancies. Safety checklists are used to minimize errors and complications, and it has been proven safe for many patients, although the risks for larger tumors are less understood. ^{6 7 8 9 10}

How is the treatment Radiosurgery unique for brain tumors?

Radiosurgery (SRS) is unique because it uses focused beams of radiation to target brain tumors precisely, allowing treatment of deep-seated areas without invasive surgery. It is often used for brain metastases and can be an alternative to whole-brain radiation therapy, offering a non-invasive option with potentially fewer side effects. ^{2 11 12 13 14}

Research Team

Erin Murphy, MD

Principal Investigator

Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with certain types of cancer that have spread to the brain, specifically those with 1-4 brain metastases where at least one lesion is sizable but operable. Participants must be physically able to undergo surgery and radiosurgery, have a good performance status (Karnofsky score ≥ 70), and not have specific cancers like small cell lung cancer or lymphoma.

Inclusion Criteria

I am mostly able to care for myself and carry out normal activities.

I have had targeted radiation for other tumors, not the one planned for surgery.

My cancer is not small cell lung cancer, lymphoma, or germ cell cancer.

Exclusion Criteria

I cannot join in study activities because of my health or mental condition.

I cannot or do not want to come back for all required follow-up visits.

My treatment plan cannot limit radiation to 10 Gy or less to my optic nerve/chiasm.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiosurgery

Participants undergo radiosurgery to focus x-rays directly on the tumor

1 day

1 visit (in-person)

Surgical Resection

Within 2 weeks of radiosurgery, participants undergo surgical resection of brain metastases

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and long-term outcomes after treatment

Up to 3 years

Treatment Details

Interventions

• Radiosurgery (Radiation Therapy)
• Therapeutic Conventional Surgery (Procedure)

Trial Overview The study tests if using radiosurgery before surgical removal of brain tumors can prevent them from returning. It aims to find the safest dose of focused x-ray radiation (radiosurgery) that causes minimal damage to healthy brain tissue while being effective against tumors.

Participant Groups

Group I: Treatment (radiosurgery, surgery) Experimental Treatment 3 Interventions

Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.

Radiosurgery is already approved in Canada, Japan for the following indications:

Approved in Canada as Stereotactic Radiosurgery for:

• Brain metastases
• Arteriovenous malformations (AVMs)
• Benign brain tumors
• Malignant brain tumors

Approved in Japan as Gamma Knife Radiosurgery for:

• Brain metastases
• Arteriovenous malformations (AVMs)
• Benign brain tumors
• Malignant brain tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic, Case Comprehensive Cancer Center Cleveland, OH

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Patients Recruited

33,400+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Role of Gamma Knife Stereotactic Radiosurgery in Neuro-Oncology. Desai, R., Rich, KM.[2020]

Stereotactic radiosurgery (SRS) is an effective non-invasive technique for targeting deep brain lesions with high doses of radiation, but it does not provide benefits for newly diagnosed malignant gliomas.

For patients with brain metastases, SRS can improve median survival when combined with whole-brain radiation therapy (WBRT), and in some cases, SRS alone may be a viable treatment option without compromising survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of radiosurgery in the management of malignant brain tumors. Stieber, VW., Ellis, TL.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The results of resection after stereotactic radiosurgery for brain metastases. Kano, H., Kondziolka, D., Zorro, O., et al.[2010]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pattern of disease progression following stereotactic radiosurgery in malignant glioma patients. Choi, SW., Cho, KR., Choi, JW., et al.[2020]

Stereotactic radiosurgery (SRS) has been shown to improve patient outcomes and reduce toxicity compared to whole-brain radiation therapy (WBRT) for treating multiple brain metastases, based on three decades of research.

Current practices allow for the treatment of patients with 10 or more brain metastases using SRS alone, even with cumulative tumor volumes of up to 25 cm³, reflecting a shift in clinical approach due to advancements in cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for Multiple Brain Metastases Radiosurgery. Niranjan, A., Monaco, E., Flickinger, J., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lausanne checklist for safe stereotactic radiosurgery. Tuleasca, C., Zeverino, M., Patin, D., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosurgery for large-volume (> 10 cm3) benign meningiomas. Bledsoe, JM., Link, MJ., Stafford, SL., et al.[2022]

This case report highlights the first documented instance of undifferentiated high-grade pleomorphic sarcoma developing after stereotactic radiosurgery (SRS) for a presumed benign vestibular schwannoma, indicating a potential risk of malignant transformation associated with SRS.

The patient experienced a good initial response to SRS over 7.5 years, but later developed rapid tumor growth and neurological decline, emphasizing the importance of monitoring and counseling patients about the rare but serious risk of malignancy following SRS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation-induced sarcoma in a large vestibular schwannoma following stereotactic radiosurgery: case report. Schmitt, WR., Carlson, ML., Giannini, C., et al.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glioblastoma after AVM radiosurgery. Case report and review of the literature. Xhumari, A., Rroji, A., Enesi, E., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. Meisner, J., Meyer, A., Polivka, B., et al.[2021]

In a study of 64 patients with glioblastoma multiforme (GBM), those who received a gamma knife stereotactic radiosurgery (GK-SRS) boost in addition to external beam radiotherapy (EBRT) had a median overall survival of 25 months, compared to 13 months for those who received EBRT alone.

The addition of GK-SRS significantly improved survival rates without causing severe acute toxicity, indicating it is a safe and effective adjuvant therapy for GBM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamma knife stereotactic radiosurgery for patients with glioblastoma multiforme. Nwokedi, EC., DiBiase, SJ., Jabbour, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term disease outcome and volume-based decision strategy in a large cohort of multiple brain metastases treated with a mono-isocentric linac-based Stereotactic Radiosurgery technique. Alongi, F., Nicosia, L., Figlia, V., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mean Brain Dose Remains Uninfluenced by the Lesion Number for Gamma Knife Stereotactic Radiosurgery for 10+ Metastases. Sita, TL., Gopalakrishnan, M., Rooney, MK., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for the treatment of brain metastases; results from a single institution experience. Burke, D., Mascott, C., Rock, L., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Role of Gamma Knife Stereotactic Radiosurgery in Neuro-Oncology. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The role of radiosurgery in the management of malignant brain tumors. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The results of resection after stereotactic radiosurgery for brain metastases. [2010]

4. Scotland pubmed.ncbi.nlm.nih.gov

Pattern of disease progression following stereotactic radiosurgery in malignant glioma patients. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Guidelines for Multiple Brain Metastases Radiosurgery. [2019]

6. Austria pubmed.ncbi.nlm.nih.gov

Lausanne checklist for safe stereotactic radiosurgery. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Radiosurgery for large-volume (> 10 cm3) benign meningiomas. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Radiation-induced sarcoma in a large vestibular schwannoma following stereotactic radiosurgery: case report. [2011]

9. Austria pubmed.ncbi.nlm.nih.gov

Glioblastoma after AVM radiosurgery. Case report and review of the literature. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Gamma knife stereotactic radiosurgery for patients with glioblastoma multiforme. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

Long-term disease outcome and volume-based decision strategy in a large cohort of multiple brain metastases treated with a mono-isocentric linac-based Stereotactic Radiosurgery technique. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Mean Brain Dose Remains Uninfluenced by the Lesion Number for Gamma Knife Stereotactic Radiosurgery for 10+ Metastases. [2022]

14. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for the treatment of brain metastases; results from a single institution experience. [2021]