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.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is Radiosurgery a promising treatment for brain tumors?Yes, radiosurgery is a promising treatment for brain tumors. It is effective for treating brain metastases, especially when surgery is not possible. It can improve survival in some patients and is used for both initial and recurrent brain tumors.1271314
What safety data is available for radiosurgery in treating brain tumors?Stereotactic radiosurgery (SRS), including Gamma Knife radiosurgery, is generally considered a safe procedure for treating various brain conditions, including tumors. Safety guidelines and checklists, such as the Lausanne checklist, are used to minimize errors and complications. While SRS is relatively safe, there are rare reports of SRS-associated malignancies, such as glioblastoma and radiation-induced sarcoma. The safety of SRS for large-volume tumors is less understood, but it is effective for smaller brain metastases and benign meningiomas.45689
What data supports the idea that Radiosurgery for Brain Tumor is an effective treatment?The available research shows that radiosurgery, specifically Gamma Knife Stereotactic Radiosurgery (SRS), is effective for treating brain tumors like brain metastases. It can improve survival rates when used with whole-brain radiation therapy (WBRT) or even replace WBRT in some cases, without reducing survival time. SRS is also effective for patients with multiple brain metastases, improving outcomes and reducing side effects compared to WBRT. This makes it a preferred option for many doctors, especially when treating multiple tumors.23101112
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
My cancer is not small cell lung cancer, lymphoma, or germ cell cancer.
I have 1-4 brain tumors suitable for specific radiation and surgery, with one larger than 20mm but not over 50mm.
I am mostly able to care for myself and carry out normal activities.
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.
My tumor is located in the brainstem.
I am considered medically unfit for surgery to remove brain cancer.
I have had whole brain radiotherapy before.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Treatment (radiosurgery, surgery)Experimental Treatment3 Interventions
Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.
Radiosurgery is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Stereotactic Radiosurgery for:
- Brain metastases
- Arteriovenous malformations (AVMs)
- Benign brain tumors
- Malignant brain tumors
🇪🇺 Approved in European Union as Gamma Knife Radiosurgery for:
- Brain metastases
- Arteriovenous malformations (AVMs)
- Benign brain tumors
- Malignant brain tumors
🇨🇦 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 nearbySelect from list below to view details:
Cleveland Clinic, Case Comprehensive Cancer CenterCleveland, OH
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Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
References
Gamma knife stereotactic radiosurgery for patients with glioblastoma multiforme. [2022]Stereotactic radiosurgery (SRS) has become an effective therapeutic modality for the treatment of patients with glioblastoma multiforme (GBM). This retrospective review evaluates the impact of SRS delivered on a gamma knife (GK) unit as an adjuvant therapy in the management of patients with GBM.
The role of radiosurgery in the management of malignant brain tumors. [2019]Stereotactic radiosurgery (SRS) provides the means for creating lesions in deep-seated areas of the brain inaccessible to invasive surgery, using single high doses of focused ionizing radiation, administered using stereotactic guidance. It is a surgical technique designed to produce a specific radiobiological effect within a sharply defined target region in a single treatment session. Its technical application requires a stereotactic coordinate system, highly accurate patient repositioning (usually fixed), and multiple convergent beams of photon radiation. SRS appears to provide no benefit in the upfront treatment of newly diagnosed malignant gliomas but may be used to effectively palliate small well-demarcated volumes of recurrent disease. For selected patients with brain metastases treated with whole-brain radiation therapy (WBRT), the addition of SRS improves median survival. In selected patients with brain metastases, it is also rational to withhold WBRT in favor of radiosurgery alone, with WBRT reserved for salvage without a decrease in median survival time.
The results of resection after stereotactic radiosurgery for brain metastases. [2010]Radiosurgery for brain metastasis fails in some patients, who require further surgical care. In this paper the authors' goal was to evaluate prognostic factors that correlate with the survival of patients who require a resection of a brain metastasis after stereotactic radiosurgery (SRS).
Radiosurgery for large-volume (> 10 cm3) benign meningiomas. [2022]Stereotactic radiosurgery (SRS) has proven to be a safe and effective treatment for many patients with intracranial meningiomas. Nevertheless, the morbidity associated with radiosurgery of larger meningiomas is poorly understood.
Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. [2021]Efficacy and safety of the own single-center experience with moderately dosed radiosurgery (SRS) for limited (one to four) brain metastases were analyzed and correlated with patient- and treatment-related variables.
Radiation-induced sarcoma in a large vestibular schwannoma following stereotactic radiosurgery: case report. [2011]Stereotactic radiosurgery (SRS) has been employed with increasing frequency in the treatment of benign intracranial tumors. While the risk for radiation-induced malignancy has been well studied for fractionated external beam radiation, reports of SRS-associated malignancy have only begun to emerge over the past 10 years.
Stereotactic radiosurgery for the treatment of brain metastases; results from a single institution experience. [2021]Stereotactic radiosurgery is frequently used for the treatment of brain metastases. This study provides a retrospective evaluation of patients with secondary lesions of the brain treated with stereotactic radiosurgery (SRS) at our institution.
Glioblastoma after AVM radiosurgery. Case report and review of the literature. [2018]Stereotactic radiosurgery (SRS) is considered to be a relatively safe procedure in cerebral arteriovenous malformation management. There are very few reported cases of SRS-associated/induced malignancies.
Lausanne checklist for safe stereotactic radiosurgery. [2020]Stereotactic radiosurgery (SRS) is increasingly used as a minimally invasive alternative in many neurosurgical conditions, including benign and malignant tumors, vascular malformations, and functional procedures. As for any surgical procedure, strict safety guidelines and checklists are necessary to avoid errors and the inherent unnecessary complications. With regard to the former, other groups have already reported human and/or technical errors. We describe our safety checklist for Gamma Knife radiosurgical procedures.
Guidelines for Multiple Brain Metastases Radiosurgery. [2019]Stereotactic radiosurgery (SRS) is an effective treatment for patients with multiple brain metastases. Three decades of increasingly powerful scientific studies have shown that SRS improves outcomes and reduces toxicity when it replaces whole-brain radiation therapy (WBRT). Expert opinion surveys of clinicians have reported that the total intracranial tumor volume rather than the number of brain metastases is related to outcomes. As a result, an increasing number of treating and referring physicians have replaced the reflex use of WBRT with SRS, unless the patient has miliary disease or carcinomatous meningitis. In the current era of immunotherapy and targeted therapies with potentially increased systemic disease survival, 10 or more tumors are routinely treated with SRS alone at most academic medical centers. In a single SRS session we routinely treat patients with cumulative tumor volumes of 25 cm3 even if they have ≥10 metastases.
Therapeutic Role of Gamma Knife Stereotactic Radiosurgery in Neuro-Oncology. [2020]The Gamma Knife Center of St. Louis has established itself as a key facility offering stereotactic radiosurgery (SRS) for a variety of neuro-oncologic disorders. Since the Gamma Knife unit was first brought to Washington University in 1997, we have treated 5,696 patients. In this review, we discuss the effective role of Gamma Knife SRS in the treatment strategies for patients with neuro-oncologic disorders including brain metastases, meningiomas, pituitary adenomas, and acoustic neuromas. While there is active ongoing research evaluating the most effective treatment for patients with these disorders, it is clear that best management practices may be tailored for individual patients utilizing SRS either alone or in conjunction alternative treatment strategies including open neurosurgical procedures, laser thermos-ablative surgery, and even new medical oncological treatment strategies.
Pattern of disease progression following stereotactic radiosurgery in malignant glioma patients. [2020]The clinical benefit of stereotactic radiosurgery (SRS) in the treatment of malignant glioma remains controversial. We analyzed failure patterns of malignant gliomas following SRS to identify the clinical implications of SRS against these malignancies.
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]Radiosurgery (SRS) is an effective treatment option for brain metastases (BMs). Long-term results of the first worldwide experience with a mono-isocentric, non-coplanar, linac-based stereotactic technique in the treatment of multiple BMs are reported.
Mean Brain Dose Remains Uninfluenced by the Lesion Number for Gamma Knife Stereotactic Radiosurgery for 10+ Metastases. [2022]Gamma Knife (GK) stereotactic radiosurgery (SRS) is increasingly used as an initial treatment for patients with 10 or more brain metastases. However, the clinical and dosimetric consequences of this practice are not well established.