20 Participants Needed

Pre-Op SRS Before Surgery for Brain Metastases

SC
CT
Overseen ByClinical Trials Contact
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a research study to determine if performing stereotactic radiosurgery (SRS) prior to surgical resection of the brain metastasis (tumor) will improve local control, in other words, increase the possibility of total removal of the primary tumor without local recurrence on longterm follow up. This research study will also determine if pre-operative SRS will lower the risk of radionecrosis that is the breakdown of body tissue at the original tumor site, and the development of leptomeningeal disease.

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's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Pre-operative Stereotactic Radiosurgery for brain metastases?

Research suggests that pre-operative stereotactic radiosurgery (SRS) before surgery for brain metastases may reduce the risk of radiation side effects and lower the chance of cancer spreading to the brain's protective layers. It also helps in better targeting the tumor, potentially leading to improved treatment outcomes.12345

Is preoperative stereotactic radiosurgery (SRS) safe for treating brain metastases?

Preoperative SRS for brain metastases is generally considered safe, with studies showing a low risk of radiation necrosis (damage to healthy brain tissue) and leptomeningeal disease (spread of cancer to the lining of the brain). It may offer advantages over postoperative SRS by reducing the volume of healthy brain exposed to radiation and potentially lowering the risk of adverse effects.23678

How is pre-operative stereotactic radiosurgery different from other treatments for brain metastases?

Pre-operative stereotactic radiosurgery (SRS) is unique because it is given before surgery, which helps to better target the tumor and reduce the risk of spreading cancer cells during surgery. This approach can also lower the chance of radiation side effects and improve control over the cancer compared to traditional post-operative treatments.247910

Research Team

RE

Rodney E Wegner, MD

Principal Investigator

AHN Radiation Oncology

Eligibility Criteria

This trial is for adults with solid tumor brain metastases who can consent to treatment, have a Karnofsky Performance Status of ≥70 (meaning they are able to care for themselves), and agree to use contraception. They must be planning surgery for at least one brain metastasis smaller than 5 cm. Those with serious medical or psychiatric illnesses, prior whole-brain radiation, or pregnant women cannot participate.

Inclusion Criteria

My cancer has spread to my brain.
I had a brain MRI less than a month before starting brain SRS.
I am 18 years old or older.
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Exclusion Criteria

I need assistance with my daily activities.
I have had whole brain radiation therapy or stereotactic radiosurgery on the main tumor.
Patients must not have a serious medical or psychiatric illness that would in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stereotactic Radiosurgery (SRS)

Participants undergo stereotactic radiosurgery using the Elekta Gamma Knife Icon, treated in once daily or every other day 15 minute fractions of 9 Gy for a total dose of 27 Gy in 3 doses

1 week
3 visits (in-person)

Surgical Resection

Routine surgical resection of the brain metastasis is performed within two weeks after completion of SRS

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with MRIs performed and quality of life questionnaires completed

2 years
Regular visits (in-person) every 3 months

Treatment Details

Interventions

  • Pre-operative Stereotactic Radiosurgery
Trial OverviewThe study tests if performing stereotactic radiosurgery (SRS) before surgical removal of the brain tumor improves chances of complete removal without recurrence and reduces risks like tissue breakdown at the tumor site and leptomeningeal disease development.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pre-Operative Stereotactic Radiosurgery (SRS)Experimental Treatment1 Intervention
Subjects are treated using the standard of care SRS to a total dose of 24-27 Gray (Gy) in 3 fractions with a once daily fractionation or every other day at treating physician discretion. The preferred dose will be 27 Gy, with ability to drop dose down to 24 Gy if normal tissue constraints cannot be met. It should be noted, that while the dosing remains within standard of care, the timing of the radiation (pre-operative) is still not considered standard of care but is supported by emerging data as described in the study background. Additional metastatic lesions may be treated using SRS according to institutional practices. The radiation dose prescribed to the non-index lesions is at the discretion of the treating physicians. Surgical resection will be performed within 2 weeks of completion of SRS.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials
52
Recruited
13,000+

Elekta Limited

Industry Sponsor

Trials
13
Recruited
8,900+

Findings from Research

Pre-operative stereotactic radiosurgery (SRS) for brain metastases significantly reduces dose exposure to healthy brain tissue compared to post-operative SRS, with a median volume receiving 28 Gy being lower in the pre-operative setting (6.79 ccm) than in the extended field post-operative setting (10.79 ccm).
The study found that the morphology of the resection cavity post-surgery differs significantly from the original lesion, which could complicate treatment planning; thus, pre-operative SRS may provide better delineation and treatment planning advantages.
Pre-Operative Versus Post-Operative Radiosurgery of Brain Metastases-Volumetric and Dosimetric Impact of Treatment Sequence and Margin Concept.El Shafie, RA., Tonndorf-Martini, E., Schmitt, D., et al.[2020]
In a study of 404 patients with brain metastases, preoperative stereotactic radiosurgery (SRS) showed low rates of cavity local recurrence (13.7%) and adverse radiation effects (7.4%), indicating it is a safe option before surgical resection.
The median overall survival for patients receiving preoperative SRS was 17.2 months, with factors like systemic disease status and extent of resection significantly influencing survival outcomes.
Risk Factors for Progression and Toxic Effects After Preoperative Stereotactic Radiosurgery for Patients With Resected Brain Metastases.Prabhu, RS., Akinyelu, T., Vaslow, ZK., et al.[2023]
This multicenter, randomized controlled trial aims to determine whether preoperative stereotactic radiosurgery (SRS) is more effective than postoperative SRS in managing resectable brain metastases, involving 88 patients over three years.
The primary goal is to assess local control of the tumors at 12 months, while secondary outcomes will evaluate overall survival, recurrence rates, neurocognitive effects, and adverse events like radiation necrosis, addressing a significant gap in current treatment protocols.
A phase III, multicenter, randomized controlled trial of preoperative versus postoperative stereotactic radiosurgery for patients with surgically resectable brain metastases.Das, S., Faruqi, S., Nordal, R., et al.[2023]

References

Preoperative Versus Postoperative Radiosurgery of Brain Metastases: A Meta-Analysis. [2023]
Pre-Operative Versus Post-Operative Radiosurgery of Brain Metastases-Volumetric and Dosimetric Impact of Treatment Sequence and Margin Concept. [2020]
Risk Factors for Progression and Toxic Effects After Preoperative Stereotactic Radiosurgery for Patients With Resected Brain Metastases. [2023]
Preoperative Stereotactic Radiosurgery of Brain Metastases: Preliminary Results. [2020]
A phase III, multicenter, randomized controlled trial of preoperative versus postoperative stereotactic radiosurgery for patients with surgically resectable brain metastases. [2023]
Outcome of moderately dosed radiosurgery for limited brain metastases. Report of a single-center experience. [2021]
Preoperative Stereotactic Radiosurgery for Brain Metastases. [2020]
Preoperative stereotactic radiosurgery before planned resection of brain metastases: updated analysis of efficacy and toxicity of a novel treatment paradigm. [2021]
Stereotactic radiosurgery and radiotherapy for resected brain metastases: current pattern of care in the Radiosurgery and Stereotactic Radiotherapy Working Group of the German Association for Radiation Oncology (DEGRO). [2022]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Palliative Resection of Metastatic Brain Tumors Previously Treated by Stereotactic Radiosurgery. [2020]