Pre-Surgical Radiosurgery for Brain Metastases
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: Emory University
Must not be taking: Immunosuppressants, Investigational agents
Disqualifiers: HIV, Uncontrolled illness, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressive medications other than dexamethasone or if you are receiving other investigational agents.
What data supports the effectiveness of the treatment Pre-Surgical Radiosurgery for Brain Metastases?
Research shows that stereotactic radiosurgery (SRS), like CyberKnife, can effectively manage brain metastases by targeting specific areas with high doses of radiation, potentially improving survival without the need for whole-brain radiation therapy (WBRT). This approach may help maintain cognitive function and quality of life compared to traditional methods.
12345Is pre-surgical radiosurgery for brain metastases safe for humans?
Research shows that stereotactic radiosurgery (SRS), including methods like Gamma Knife and CyberKnife, is generally safe for treating brain metastases, with safety guidelines and checklists in place to minimize risks. Studies have evaluated the safety of SRS for both small and large brain metastases, indicating it is a viable option with manageable toxicity.
36789How is pre-surgical radiosurgery for brain metastases different from other treatments?
Pre-surgical radiosurgery (SRS) for brain metastases is unique because it is performed before surgical removal of the tumor, which helps to better define the treatment area and reduce radiation exposure to healthy brain tissue. This approach can potentially improve precision and safety compared to post-operative SRS or whole brain radiation therapy (WBRT).
310111213Eligibility Criteria
This trial is for adults over 18 with cancer that has spread to the brain, visible on MRI. They must have a life expectancy of more than 12 weeks, be able to undergo surgery, and follow study procedures. Pregnant or nursing women, those on immunosuppressants (except dexamethasone), or with certain serious illnesses can't participate.Inclusion Criteria
Life expectancy > 12 weeks as determined by the investigator
I am willing and able to follow the study's schedule and procedures.
I can take care of myself but might not be able to do heavy physical work.
+6 more
Exclusion Criteria
I am taking immunosuppressive medication, but not dexamethasone.
Pregnant or nursing women are excluded
Human immunodeficiency virus (HIV)-positive
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Patients undergo stereotactic radiosurgery (SRS) to the brain metastasis for 1-3 fractions over 1-5 days and receive dexamethasone until the day of surgical resection
1-3 weeks
Surgery
Patients undergo surgical resection of the brain metastasis
1 week
Follow-up
Participants are monitored for safety and effectiveness after treatment
120 days, then every 12 weeks
Participant Groups
The trial tests if stereotactic radiosurgery before surgery can prevent cancer from returning in patients with brain metastases. It's an early phase I trial focused on understanding side effects and how well this pre-surgery radiation works as a treatment.
2Treatment groups
Experimental Treatment
Group I: Arm B (SRS, high dose dexamethasone, surgery)Experimental Treatment2 Interventions
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
Group II: Arm A (SRS, low dose dexamethasone, surgery)Experimental Treatment3 Interventions
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
Resection is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Surgical Resection for:
- Colorectal Cancer
- Liver Metastases
- Lung Metastases
🇪🇺 Approved in European Union as Surgical Excision for:
- Colorectal Cancer
- Liver Metastases
- Lung Metastases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory University Hospital/Winship Cancer InstituteAtlanta, GA
Loading ...
Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Cumulative volumetric analysis as a key criterion for the treatment of brain metastases. [2018]Recent studies have demonstrated diminished cognitive function, worse quality of life, and no overall survival benefit from the addition of adjuvant whole brain radiation therapy (WBRT) to stereotactic radiosurgery (SRS) in the management of brain metastases. This study analyzes the treatment outcome of SRS, specifically CyberKnife Radiosurgery, based on the total tumor volume compared to the absolute number of lesions.
Stereotactic radiosurgery for brain metastases from breast cancer. [2019]Stereotactic radiosurgery is an alternative to resection or to radiotherapy alone for patients with brain metastases. Outcomes after radiosurgery for patients with brain metastases specifically from breast cancer have not been defined.
Intracranial control after Cyberknife radiosurgery to the resection bed for large brain metastases. [2018]Stereotactic radiosurgery (SRS) is an alternative to post-operative whole brain radiation therapy (WBRT) following resection of brain metastases. At our institution, CyberKnife (CK) is considered for local treatment of large cavities ≥2 cm. In this study, we aimed to evaluate patterns of failure and characterize patients best suited to treatment with this approach.
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.
A matched-pair analysis comparing whole-brain radiotherapy plus stereotactic radiosurgery versus surgery plus whole-brain radiotherapy and a boost to the metastatic site for one or two brain metastases. [2009]To compare the results of whole-brain radiotherapy plus stereotactic radiosurgery (WBRT+SRS) with those of surgery plus whole-brain radiotherapy and a boost to the metastatic site (OP+WBRT+boost) for patients with one or two brain metastases.
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.
Fractionated stereotactic radiosurgery for large brain metastases. [2018]Large brain metastases (>3 cm) present a therapeutic dilemma, as the dose delivered by stereotactic radiosurgery (SRS) in a single fraction is limited by toxicity to adjacent tissues, resulting in suboptimal local control. This study assessed the efficacy and safety of fractionated SRS for the treatment of large brain metastases.
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.
Fractionated Stereotactic Gamma Knife Radiosurgery for Large Brain Metastases: A Retrospective, Single Center Study. [2022]Stereotactic radiosurgery (SRS) is widely used for brain metastases but has been relatively contraindicated for large lesions (>3 cm). In the present study, we analyzed the efficacy and toxicity of hypofractionated Gamma Knife radiosurgery to treat metastatic brain tumors for which surgical resection were not considered as the primary treatment option.
Multimodality treatment of brain metastases: an institutional survival analysis of 275 patients. [2022]Whole brain radiation therapy (WBRT), surgical resection, stereotactic radiosurgery (SRS), and combinations of the three modalities are used in the management of patients with metastatic brain tumors. We present the previously unreported survival outcomes of 275 patients treated for newly diagnosed brain metastases at Cancer Care Northwest and Gamma Knife of Spokane between 1998 and 2008.
A matched-pair analysis comparing stereotactic radiosurgery with whole-brain radiotherapy for patients with multiple brain metastases. [2021]Stereotactic radiosurgery (SRS) is an emerging treatment for patients with multiple brain metastases (BM). The present work compares the SRS of multiple brain metastases with whole-brain radiotherapy (WBRT).
Predictors of linear accelerator versus Gamma Knife stereotactic radiosurgery use for brain metastases in the United States. [2022]Stereotactic radiosurgery (SRS) for brain metastases is predominantly delivered via single-fraction Gamma Knife SRS (GKRS) or linear accelerator (LINAC) in up to five fractions. Predictors of SRS modality have been sparsely examined on a nationwide level.
Pre-Operative Versus Post-Operative Radiosurgery of Brain Metastases-Volumetric and Dosimetric Impact of Treatment Sequence and Margin Concept. [2020]Pre-operative radiosurgery (SRS) preceding the resection of brain metastases promises to circumvent limitations of post-operative cavity SRS. It minimizes uncertainties regarding delineation and safety margins and could reduce dose exposure of the healthy brain (HB).