Pre-Surgery Radiosurgery for Brain Tumor

Overseen By Cynthia Martin

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Cedars-Sinai Medical Center

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

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to study if giving radiation to a brain tumor (a procedure called radiosurgery) before neurosurgery (surgery to remove the tumor) will help to keep brain tissue healthy, while possibly eliminating the need to return for radiation once a patient has healed from neurosurgery. This study will also seek the best radiation dose on a brain tumor based on how well the radiation therapy works and asses the side-effects.

Will I have to stop taking my current medications?

The trial requires that you stop taking methotrexate, adriamycin, epirubicine, or navelbin for one week before or during the study. Other medications will be reviewed individually to see if they are suitable for the study.

What data supports the effectiveness of the treatment Neoadjuvant Stereotactic Radiosurgery, Neurosurgical Resection for brain tumors?

Stereotactic radiosurgery, a key part of this treatment, has been shown to be effective in controlling brain metastases and is used in various settings, including pre- and postoperative scenarios. It is known for delivering high doses of radiation precisely to the tumor, which can help in long-term control of visible tumors. ^{1 2 3 4 5}

Is pre-surgery radiosurgery for brain tumors safe?

Pre-surgery radiosurgery, also known as stereotactic radiosurgery (SRS), has been shown to be generally safe for treating brain tumors, with benefits like sparing healthy tissue and reducing certain risks compared to other methods. However, there are potential risks such as radiation necrosis (tissue damage from radiation) and the long-term risk of developing new brain tumors, though these risks are not fully understood. ^{6 7 8 9 10}

How is pre-surgery radiosurgery for brain tumors different from other treatments?

Pre-surgery radiosurgery for brain tumors is unique because it is administered before surgery, which can help reduce the size of the treatment area and minimize damage to healthy brain tissue. This approach may also lower the risk of complications like radiation necrosis (tissue damage from radiation) and leptomeningeal disease (cancer spread to the brain's lining) compared to traditional post-surgery radiation treatments. ^{8 11 12 13 14}

Research Team

Stephen Shiao, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults with a life expectancy of at least 3 months who have certain types of cancer, excluding small cell lung cancer, lymphoma, and germ cell cancers. They must have one brain tumor suitable for surgery and radiosurgery, be able to follow study requirements, not be pregnant if applicable, and have a performance status indicating they are mostly independent.

Inclusion Criteria

Life expectancy ≥ 3 months

I have a brain lesion smaller than 40 mm that can be removed or treated with SRS.

Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study

Exclusion Criteria

I am taking specific cancer drugs and will discuss my treatment with the study leader.

I have had whole brain radiation in the last three months.

I have more than 4 brain metastases.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive neoadjuvant stereotactic radiosurgery prior to neurosurgical resection

1-2 weeks

Neurosurgery

Participants undergo neurosurgical resection of the indexed brain metastasis

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of maximum tolerated dose and adverse events

1 month

Long-term follow-up

Participants are monitored for long-term outcomes, including rates of salvage treatment

3 years

Treatment Details

Interventions

• Neoadjuvant Stereotactic Radiosurgery
• Neurosurgical Resection

Trial Overview The trial tests whether giving stereotactic radiosurgery (a type of focused radiation therapy) before surgically removing brain tumors can improve outcomes and reduce the need for additional treatments. It also aims to determine the best dose of radiation by monitoring effectiveness and side effects.

Participant Groups

Group I: Neoadjuvant stereotactic radiosurgery Experimental Treatment 2 Interventions

Stereotactic radiosurgery will be performed prior to neurosurgical resection of the indexed brain metastasis. The dose of radiation to be administered to the indexed lesion will be established as a function of tumor size.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

A novel deep learning model using MRI and clinical data was developed to predict local control or failure of brain metastases after stereotactic radiation therapy, showing improved accuracy over standard clinical variables.

The best-performing model achieved an area under the curve (AUC) of 0.86, indicating strong predictive capability, particularly highlighting the significance of tumor margins in determining treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the outcome of radiotherapy in brain metastasis by integrating the clinical and MRI-based deep learning features. Jalalifar, SA., Soliman, H., Sahgal, A., et al.[2023]

Stereotactic radiosurgery (SRS) was safely administered to 30 patients with malignant gliomas after standard radiotherapy, showing no significant acute or late toxicity, which suggests it is a feasible option for dose escalation in treatment.

The study reported a median survival of 13.9 months, with 1- and 2-year disease-specific survival rates of 57% and 25%, respectively, indicating that while SRS can be effective, further research is needed to fully understand its impact on long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery as an adjunct to surgery and external beam radiotherapy in the treatment of patients with malignant gliomas. Gannett, D., Stea, B., Lulu, B., et al.[2022]

In a study of 115 patients with malignant gliomas, the addition of stereotactic radiosurgery to conventional treatments significantly improved 2-year survival rates, particularly for patients in worse prognostic classes (classes 3-6).

The median survival for patients treated with radiosurgery was 96 weeks, compared to historical data showing lower survival rates, indicating that radiosurgery may enhance treatment outcomes, although further research through randomized trials is needed to confirm its role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosurgery in the initial management of malignant gliomas: survival comparison with the RTOG recursive partitioning analysis. Radiation Therapy Oncology Group. Sarkaria, JN., Mehta, MP., Loeffler, JS., et al.[2022]

Stereotactic radiosurgery is an effective and noninvasive treatment for brain metastases, providing ablative doses of radiation for long-term control of macroscopic disease, especially in patients with a limited number of metastases.

While there is mature data supporting the use of stereotactic radiosurgery in combination with whole-brain radiation therapy, more prospective randomized studies are needed to clarify its effectiveness in patients with multiple metastases and in various treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery for Treatment of Brain Metastases. Badiyan, SN., Regine, WF., Mehta, M.[2018]

In a study of 404 patients with brain metastases, preoperative stereotactic radiosurgery (SRS) showed low rates of cavity local recurrence (13.7%) and adverse radiation effects (7.4%), indicating it is a safe option before surgical resection.

The median overall survival for patients receiving preoperative SRS was 17.2 months, with factors like systemic disease status and extent of resection significantly influencing survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Progression and Toxic Effects After Preoperative Stereotactic Radiosurgery for Patients With Resected Brain Metastases. Prabhu, RS., Akinyelu, T., Vaslow, ZK., et al.[2023]

In a study of 4905 patients who underwent Gamma Knife stereotactic radiosurgery, the long-term risk of developing secondary intracranial malignancies or malignant transformation of benign tumors was found to be very low, with an incidence of 6.8 per 100,000 patient-years, similar to the general population's risk.

The findings suggest that stereotactic radiosurgery is a safe treatment option for conditions like benign tumors and arteriovenous malformations, providing reassurance for patients and physicians regarding its long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of radiation-associated intracranial malignancy after stereotactic radiosurgery: a retrospective, multicentre, cohort study. Wolf, A., Naylor, K., Tam, M., et al.[2020]

In a study of 75 patients with WHO Grade I meningiomas treated with stereotactic radiosurgery (SRS), 52% showed no volumetric tumor growth, while 92% had stable diametric measurements, indicating that SRS is effective in controlling tumor growth in most cases.

A lower conformity index was significantly linked to the development of edema post-SRS, suggesting that careful planning of radiation delivery can help minimize adverse effects like swelling in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of response to Gamma Knife radiosurgery for intracranial meningiomas. Mansouri, A., Larjani, S., Klironomos, G., et al.[2022]

Pre-operative stereotactic radiosurgery (SRS) for brain metastases significantly reduces dose exposure to healthy brain tissue compared to post-operative SRS, with a median volume receiving 28 Gy being lower in the pre-operative setting (6.79 ccm) than in the extended field post-operative setting (10.79 ccm).

The study found that the morphology of the resection cavity post-surgery differs significantly from the original lesion, which could complicate treatment planning; thus, pre-operative SRS may provide better delineation and treatment planning advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Operative Versus Post-Operative Radiosurgery of Brain Metastases-Volumetric and Dosimetric Impact of Treatment Sequence and Margin Concept. El Shafie, RA., Tonndorf-Martini, E., Schmitt, D., et al.[2020]

References

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

Predicting the outcome of radiotherapy in brain metastasis by integrating the clinical and MRI-based deep learning features. [2023]

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

Stereotactic radiosurgery as an adjunct to surgery and external beam radiotherapy in the treatment of patients with malignant gliomas. [2022]

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

Radiosurgery in the initial management of malignant gliomas: survival comparison with the RTOG recursive partitioning analysis. Radiation Therapy Oncology Group. [2022]

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

A comparison of surgical resection and stereotactic radiosurgery in the treatment of solitary brain metastases. [2022]

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

Stereotactic Radiosurgery for Treatment of Brain Metastases. [2018]

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

Preoperative Radiosurgery for Resected Brain Metastases: The PROPS-BM Multicenter Cohort Study. [2022]

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

Risk Factors for Progression and Toxic Effects After Preoperative Stereotactic Radiosurgery for Patients With Resected Brain Metastases. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Preoperative stereotactic radiosurgery in the management of brain metastases and gliomas. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Risk of radiation-associated intracranial malignancy after stereotactic radiosurgery: a retrospective, multicentre, cohort study. [2020]

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

Predictors of response to Gamma Knife radiosurgery for intracranial meningiomas. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Pre-Operative Versus Post-Operative Radiosurgery of Brain Metastases-Volumetric and Dosimetric Impact of Treatment Sequence and Margin Concept. [2020]

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

Preoperative Stereotactic Radiosurgery of Brain Metastases: Preliminary Results. [2020]

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

Single-Fraction Versus Fractionated Preoperative Radiosurgery for Resected Brain Metastases: A PROPS-BM International Multicenter Cohort Study. [2023]

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

Pre-operative stereotactic radiosurgery for cerebral metastatic disease: A retrospective dose-volume study. [2023]