Radiosurgery for Brain Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Disqualifiers: Glioma, Brain tumor, Chemotherapy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that planned chemotherapy during radiosurgery is not allowed, which might imply some restrictions on certain treatments.
What data supports the effectiveness of this treatment for brain cancer?
Research on stereotactic ablative radiotherapy (SABR) using the CyberKnife system shows high rates of local tumor control and acceptable safety for lung tumors, suggesting potential effectiveness for other cancers, including brain cancer.
12345Is stereotactic radiosurgery generally safe for humans?
Stereotactic radiosurgery, including treatments like CyberKnife, has been used safely for various cancers, such as lung and prostate cancer, with some reports of serious complications. However, strategies are in place to reduce these risks, and the treatment is generally considered to have acceptable safety levels.
12367How is the treatment Stereotactic Radiosurgery unique for brain cancer?
Stereotactic Radiosurgery (SRS) is unique because it delivers high doses of radiation precisely to the tumor in a short period, minimizing damage to surrounding healthy tissue. This makes it a non-invasive alternative to traditional surgery, especially useful for patients with large brain metastases or those who cannot undergo surgery.
12589Eligibility Criteria
This trial is for adults with solid tumor cancers, except SCLC and germ cell tumors, who have 1-10 brain metastases. They must be in good enough health to follow the study plan and complete cognitive tests. Pregnant women or those planning chemotherapy during radiosurgery are excluded.Inclusion Criteria
Patient able to provide his/her own written informed consent and speak English
I can care for myself but may need occasional help.
I have a confirmed solid tumor cancer, not including small cell lung or germ cell tumors.
+6 more
Exclusion Criteria
I have had more than one seizure per week despite taking seizure medication.
I have been diagnosed with a grade II-IV primary brain tumor.
I had brain surgery less than 14 days ago.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline
1 week
1-3 visits (in-person)
Follow-up
Participants are monitored for neurocognitive function and other outcomes at 2, 4, 6, 8, 10, and 12 months after treatment
12 months
6 visits (in-person)
Participant Groups
The trial is testing how stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT) affects neurological function in patients with multiple brain metastases. It aims to determine if SRS better preserves neurocognition than SBRT.
1Treatment groups
Experimental Treatment
Group I: Supportive care (SRS/SBRT, neurocognitive testing)Experimental Treatment4 Interventions
Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
🇦🇺 Approved in Australia as Stereotactic Body Radiation Therapy for:
- Non-small cell lung cancer (NSCLC)
- Melanoma
- Renal cell carcinoma (RCC)
- Prostate cancer
- Oligoprogressive cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Jefferson Health New JerseySewell, NJ
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphia, PA
Aria HealthPhiladelphia, PA
Reading HospitalReading, PA
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Who Is Running the Clinical Trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]Stereotactic ablative radiotherapy (SABR) has emerged as a promising treatment for early stage non-small cell lung cancer, particularly for patients unable to tolerate surgical resection. High rates of local tumor control have been demonstrated with acceptable toxicity and the practical advantage of a short course of treatment. The CyberKnife image-guided robotic radiosurgery system has unique technical characteristics that make it well suited for SABR of tumors that move with breathing, including lung tumors. We review the qualities of the CyberKnife platform for lung tumor SABR, and provide a summary of clinical data using this system specifically.
Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]Stereotactic ablative body radiotherapy (SABR) provides a superior non-small cell lung cancer (NSCLC) treatment option when compared to conventional radiotherapy for patients deemed inoperable or refusing surgery. This study retrospectively analyzed the rates of tumor control and toxicity following SABR treatment (Cyberknife system) of primary early-stage NSCLC in a community setting.
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.
Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. [2023]The CyberKnife system features a robotically-positioned linear accelerator to deliver real-time image-guided stereotactic ablative body radiotherapy (SABR). It achieves steep dose gradients using irradiation from hundreds of different directions and increases the central dose of the gross tumor volume (GTV) without increasing the marginal dose to the planning target volume. We evaluated the effectiveness and safety of SABR with a central high dose using CyberKnife for metastatic lung tumors.
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]Stereotactic ablative body radiotherapy (SABR) is an emerging noninvasive approach for the treatment of oligometastases. Limited prospective evidence is available in breast cancer.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]The clinical applications of stereotactic body radiotherapy or stereotactic ablative radiotherapy (SABR) for the treatment of primary and metastatic tumours of different organ sites have been expanding rapidly in the recent decade. SABR requires advanced technology in radiotherapy planning and image guidance to deliver a highly conformal ablative dose precisely to targets (or tumours) in the body. Although this treatment modality has shown promising results with regard to tumour control, some serious complications have been observed and reported. In order to achieve a favourable therapeutic ratio, strategies to mitigate the risk of complications must be in place. This overview will summarise the reported serious complications caused by SABR and strategies to mitigate the risk will be discussed.
Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). [2022]While conventional treatment relies on protracted courses of therapy using relatively small dose-per-fraction sizes of 1.8-2Gy, there is substantial evidence gathered over decades that this may not be the optimal approach for all targetable disease. Stereotactic ablative body radiosurgery (SABR) or stereotactic body radiation therapy (SBRT) is a technique which uses precise targeting to deliver high doses of radiation capable of ablating tumors directly. In this review, we will discuss the justification for and techniques used to deliver ablative doses to improve treatment outcomes, interactions with biological and immunologic therapy, and special procedures to spare normal tissue, which have facilitated the expanding role for these techniques in the management of a wide range of malignant histologies and disease states.
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.