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

May 5, 2022 updated by: Michael Milano, MD,PhD, University of Rochester

Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Department of Radiation Oncology, University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated at the University of Rochester Medical Center

Description

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:

  • KPS<60
  • life expectancy > 2 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Treatment using Novalis SRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine toxicity of treatment with cranial SRS and resection
Time Frame: During treatment and long term follow-up
During treatment and long term follow-up
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
During treatment and long term follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Following surgical resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Michael Milano, MD PhD, Department of Radiation Oncology, University of Rochester Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2009

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

March 28, 2022

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URBT07099
  • RSRB00023405 (Other Identifier: Univ of Rochester IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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