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CompletedNCT00904553Updated May 9, 2022

Study of Resection Combined With Stereotactic Radiosurgery for 1 to 3 Brain Metastases

An observational study in Neoplasm Metastasis, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by University of Rochester · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
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Study summary

This study is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment.

The purpose of this study is to determine what side effects are common or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other brain metastases.

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Conditions studied

  • Neoplasm Metastasis

Keywords

  • Brain
  • metastases
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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 25 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated at the University of Rochester Medical Center

Inclusion criteria

  • Patients must have a previously histopathologically proven diagnosis of malignancy.
  • Patients must be evaluated by Neurosurgery and Radiation Oncology
  • Patients must have 1-3 brain metastases seen on MRI or CT imaging. At least one brain metastases must be considered resectable by craniotomy as determined by the treating neurosurgeon. Brain lesion resection must be considered standard of care. A not uncommon situation is for a patient to undergo resection of a solitary metastasis, but prove to have more lesions on subsequent MRIs (perhaps too small to be seen on a pre-operative MRI). These patients will be eligible if the total number of lesions is 1-3.
  • All lesions must be treatable by SRS as determined by the treating neurosurgeon and radiation oncologist.
  • All lesions must be \<4 cm in greatest dimension. For patients with more than 1 brain metastases, only 1 lesion can exceed 3 cm in greatest dimension.
  • In patients treated to the post-op surgical cavity, this cavity must be encompassed by a CTV of \<5 cm.
  • Patients must have a Karnofsky performance status ≥60.
  • Extracranial disease must not be considered imminently life threatening (\<2 month anticipated survival from extracranial disease).
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion criteria

Exclusion Criteria:

  • KPS\<60
  • life expectancy > 2 months
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Novalis Shaped Beam Surgery

    Patients with limited brain metastases (mostly solitary brain metastasis) treated with Novalis Shaped Beam Surgery followed by planned craniotomy and resection of the metastases.

    Radiation: Novalis Shaped Beam Surgery

Interventions

  • RadiationNovalis Shaped Beam Surgery

    Treatment using Novalis SRS

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What researchers measure

Primary outcomes

  1. Determine toxicity of treatment with cranial SRS and resection

    Time frame: During treatment and long term follow-up

  2. Determine the local control of the treated lesion(s), distant brain control and overall patient survival.

    Time frame: During treatment and long term follow-up

Secondary outcomes

  1. Tissue from the resected brain metastases will be evaluated with immunohistochemistry and/or comparative genomic hybridization to assess for potential markers for clinical outcome as well as potential markers of radiation response.

    Time frame: Following surgical resection

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Study locations

1 site
  • Department of Radiation Oncology, University of Rochester Medical Center
    Rochester, New York 14642, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00904553
Lead sponsor
University of Rochester
Responsible party
Michael Milano, MD,PhD (Associate Professor, University of Rochester) — Principal investigator
First posted
May 19, 2009
Start date
Jan 14, 2009
Primary completion
Mar 28, 2022
Completion
Mar 28, 2022
Last update
May 9, 2022

Study contacts

Michael Milano, MD PhD
principal investigator · Department of Radiation Oncology, University of Rochester Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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