135 Participants Needed

Stereotactic Radiosurgery for Brain Cancer

(SRS Trial)

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Overseen ByJonathan VanPelt, MHA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Stereotactic Radiosurgery for brain cancer?

Research shows that Stereotactic Radiosurgery (SRS) is effective for treating brain metastases, improving outcomes and reducing side effects compared to whole-brain radiation therapy. It is used successfully for various conditions, including large brain metastases and multiple brain tumors, with studies indicating its effectiveness in controlling tumor growth and improving patient outcomes.12345

Is stereotactic radiosurgery generally safe for humans?

Stereotactic radiosurgery (SRS) and related treatments like CyberKnife and Gamma Knife are generally considered safe, with most incidents leading to little or no patient harm. Safety studies show that errors are often related to human performance and administrative issues, rather than the treatment itself, and efforts are ongoing to improve safety practices.678910

How is the treatment Stereotactic Radiosurgery (SRS) unique for brain cancer?

Stereotactic Radiosurgery (SRS) is unique because it delivers a high dose of focused radiation to a specific area in the brain in a single session, minimizing damage to surrounding healthy tissue. This makes it an effective option for treating brain metastases and other intracranial lesions, especially in areas that are difficult to reach with traditional surgery.111121314

Research Team

RT

Robert Timmerman, MD

Principal Investigator

UTSW

Eligibility Criteria

This trial is for adults with non-hematopoietic cancer and up to 10 brain metastases, none larger than 3.0 cm or in the brain stem. Participants must not be pregnant, agree to use contraception, have an ECOG score of ≤2 or Karnofsky score ≥50, and can have had prior treatments except recent brain surgery or radiation.

Inclusion Criteria

I have 10 or fewer brain tumors.
My cancer is not related to blood, small cell lung, germ cell, or an unknown primary.
I have brain metastasis visible on MRI or CT scans.
See 8 more

Exclusion Criteria

Patients with life expectancy < 3 months
I do not have any severe illnesses that could interfere with the study.
I am not pregnant or breastfeeding.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic radiosurgery (SRS) with dose escalation to determine maximal tolerated doses

90 days
1 visit (in-person) for SRS procedure

Follow-up

Participants are monitored for safety, overall survival, time to progression, and local progression rate after treatment

3 years
Regular follow-up visits with imaging as per protocol

Treatment Details

Interventions

  • Stereotactic Radiosurgery
Trial OverviewThe study tests increasing doses of Stereotactic Radiosurgery (SRS) on patients who haven't received previous brain radiation. The goal is to find higher tolerable doses that could improve treatment outcomes like tumor control and patient survival.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Stereotactic RadiosurgeryExperimental Treatment1 Intervention
Radiation, Stereotactic Radiosurgery Dose-Escalation

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Findings from Research

Stereotactic radiosurgery (SRS) using CyberKnife for large brain metastasis cavities (≥2 cm) showed a local failure rate of 24%, indicating it can effectively control local disease after surgery.
Patients with synchronous metastases had a higher risk of distant brain failure, suggesting that while SRS can delay the need for whole brain radiation therapy (WBRT), careful monitoring is needed for those with multiple metastases.
Intracranial control after Cyberknife radiosurgery to the resection bed for large brain metastases.Vogel, J., Ojerholm, E., Hollander, A., et al.[2018]
Stereotactic radiosurgery (SRS) for patients with 5 or more melanoma brain metastases showed a high local control rate of 91.3% at 6 months and 82.2% at 12 months, indicating its effectiveness as a treatment option.
The study found that a larger planning target volume (PTV) was a significant predictor of local failure, highlighting the importance of careful treatment planning in achieving better outcomes for patients.
Potential role for LINAC-based stereotactic radiosurgery for the treatment of 5 or more radioresistant melanoma brain metastases.Frakes, JM., Figura, NB., Ahmed, KA., et al.[2016]
Both stereotactic radiosurgery (SRS) and fractionated stereotactic radiosurgery (fSRS) achieved similar local control rates for vestibular schwannomas, with SRS showing 100% and fSRS showing 94.2%.
However, fSRS was associated with a significantly higher risk of toxicities (42.3% vs. 8.3% for SRS), indicating that while both treatments are effective, fSRS may pose greater safety concerns.
Stereotactic radiosurgery and fractionated stereotactic radiosurgery for vestibular schwannomas: A comparison of clinical outcomes from the RSSearch patient registry.Singh, R., Ansinelli, H., Jenkins, J., et al.[2022]

References

Intracranial control after Cyberknife radiosurgery to the resection bed for large brain metastases. [2018]
Potential role for LINAC-based stereotactic radiosurgery for the treatment of 5 or more radioresistant melanoma brain metastases. [2016]
Stereotactic radiosurgery and fractionated stereotactic radiosurgery for vestibular schwannomas: A comparison of clinical outcomes from the RSSearch patient registry. [2022]
Linear accelerator radiosurgery in the treatment of brain metastases. [2022]
Guidelines for Multiple Brain Metastases Radiosurgery. [2019]
Common Error Pathways in CyberKnife™ Radiation Therapy. [2020]
Efficacy and safety of CyberKnife radiosurgery in elderly patients with brain metastases: a retrospective clinical evaluation. [2021]
Assessing the long-term safety and efficacy of gamma knife and linear accelerator radiosurgery for vestibular schwannoma: A systematic review and meta-analysis. [2022]
Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. [2022]
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]
Medical and health economic assessment of radiosurgery for the treatment of brain metastasis. [2021]
Stereotactically guided radiosurgery using the linear accelerator. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
The role of radiosurgery in the management of malignant brain tumors. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
The treatment of intracranial lesions with stereotactic radiosurgery. [2004]