Stereotactic Radiosurgery Timing for Brain Metastasis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Prior brain radiation, Small-cell lung cancer, Lymphoma, Leukemia, Multiple myeloma, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.
Do I need to stop my current medications for the trial?
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 Stereotactic Radiosurgery for brain metastasis?
Research shows that Stereotactic Radiosurgery (SRS) can prolong survival in patients with a single brain metastasis and maintain functional independence in those with up to three brain metastases. Additionally, SRS is effective in treating multiple brain metastases without the cognitive decline associated with whole brain radiation therapy.
12345Is stereotactic radiosurgery generally safe for humans?
Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) are generally considered safe for humans, with studies showing their use in treating various conditions like brain metastases and prostate cancer. Safety guidelines and checklists are in place to minimize errors and complications, and advancements in technology have improved their safety and accuracy.
678910How is stereotactic radiosurgery (SRS) different from other treatments for brain metastasis?
Stereotactic radiosurgery (SRS) is unique because it delivers a single, highly focused dose of radiation directly to the brain metastasis, minimizing damage to surrounding healthy tissue. Unlike whole brain radiation therapy (WBRT), SRS is associated with better cognitive outcomes and quality of life, as it targets only the tumor and not the entire brain.
411121314Eligibility Criteria
This trial is for cancer patients with brain metastases who can undergo surgery and stereotactic radiosurgery (SRS). They should have a primary lesion size within specified limits, be in good enough health as measured by performance scores, and not have had previous brain radiation. Pregnant or breastfeeding women are excluded.Inclusion Criteria
I am mostly able to care for myself and carry out daily activities.
My main cancer area is 4 cm or less for one treatment, or 7 cm or less for multiple treatments.
I am a candidate for focused radiation therapy soon after my brain surgery.
+3 more
Exclusion Criteria
I have had radiation therapy to my brain before.
For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy)
My primary cancer is either small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo SRS and surgery based on randomization to pre-operative or post-operative SRS
Up to 4 weeks
Multiple visits for SRS and surgery
Follow-up
Participants are monitored for safety, effectiveness, and neurocognitive function after treatment
Up to 1 year
Periodic visits
Long-term follow-up
Participants are monitored for long-term outcomes such as local control, distant brain control, and overall survival
Up to 4 years
Participant Groups
The study compares the effectiveness of SRS when done before surgery versus after surgery in treating brain tumors from metastasized cancer. It's a phase III trial to determine which timing works best for high-dose radiation focused on the tumors.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (pre-operative SRS)Experimental Treatment3 Interventions
Patients undergo SRS within 30 days of randomization followed by surgery within 30 days. Patients may undergo additional SRS if disease returns after treatment.
Group II: Group II (post-operative SRS)Active Control3 Interventions
Patients undergo surgery within 30 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.
Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
🇺🇸 Approved in United States as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
- Liver tumors
- Lung tumors
- Spinal cord tumors
🇨🇦 Approved in Canada as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
🇯🇵 Approved in Japan as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
🇨🇳 Approved in China as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
🇨🇭 Approved in Switzerland as Stereotactic Radiosurgery for:
- Brain tumors
- Metastatic brain tumors
- Arteriovenous malformations (AVMs)
- Trigeminal neuralgia
- Acoustic neuromas
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Potential role for LINAC-based stereotactic radiosurgery for the treatment of 5 or more radioresistant melanoma brain metastases. [2016]Linear accelerator (LINAC)-based stereotactic radiosurgery (SRS) is a treatment option for patients with melanoma in whom brain metastases have developed. Very limited data are available on treating patients with ≥5 lesions. The authors sought to determine the effectiveness of SRS in patients with ≥5 melanoma brain metastases.
Linear accelerator radiosurgery in the treatment of brain metastases. [2022]To review a 12-year experience treating metastatic brain disease with linear accelerator-based stereotactic radiosurgery (SRS).
New developments in intracranial stereotactic radiotherapy for metastases. [2022]Brain metastases are common and the prognosis for patients with multiple brain metastases treated with whole brain radiotherapy is limited. As systemic disease control continues to improve, the expectations of radiotherapy for brain metastases are growing. Stereotactic radiosurgery (SRS) as a high precision localised irradiation given in a single fraction prolongs survival in patients with a single brain metastasis and functional independence in those with up to three brain metastases. SRS technology has become commonplace and is available in many radiation oncology and neurosurgery departments. With increasing use there is a need for appropriate patient selection, refinement of dose-fractionation and safe integration of SRS with other treatment modalities. We review the evidence for current practice and new developments in the field, with a specific focus on patient-relevant outcomes.
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.
A multi-institutional study of factors influencing the use of stereotactic radiosurgery for brain metastases. [2018]Stereotactic radiosurgery (SRS) for brain metastases is a relatively well-studied technology with established guidelines regarding patient selection, although its implementation is technically complex. We evaluated the extent to which local availability of SRS affected the treatment of patients with brain metastases.
Efficacy and safety of CyberKnife radiosurgery in elderly patients with brain metastases: a retrospective clinical evaluation. [2021]Stereotactic radiosurgery (SRS) has been increasingly applied for up to 10 brain metastases instead of whole brain radiation therapy (WBRT) to achieve local tumor control while reducing neurotoxicity. Furthermore, brain-metastasis incidence is rising due to the increasing survival of patients with cancer. Our aim was to analyze the efficacy and safety of CyberKnife (CK) radiosurgery for elderly patients.
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.
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]We evaluated the effectiveness and safety of stereotactic ablative radiotherapy (SABR) delivered using Cyberknife in patients with stage I non-small-cell lung cancer.
Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]We report the results of a retrospective study of stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer. The study focused on the safety and feasibility of this treatment modality.
Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. [2022]This updated report on stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) is part of a series of consensus-based white papers previously published addressing patient safety. Since the first white papers were published, SRS and SBRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The complexity and submillimeter accuracy, and delivery of a higher dose per fraction requires an emphasis on best practices for technical, dosimetric, and quality assurance. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. [2021]Radiotherapy for patients suffering from malignant neoplasms has developed greatly during the past decades. Stereotactic radiosurgery (SRS) is one important radiotherapeutic option which is defined by a single and highly focussed application of radiation during a specified time interval. One of its important indications is the treatment of brain metastases.
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.
Comparison of stereotactic brachytherapy (125 iodine seeds) with stereotactic radiosurgery (LINAC) for the treatment of singular cerebral metastases. [2021]To compare stereotactic brachytherapy (SBT) with stereotactic radiosurgery (SRS) for treating singular cerebral metastases, regarding feasibility, complications, cerebral disease control, and survival.
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.