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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00904553
Recruitment Status : Active, not recruiting
First Posted : May 19, 2009
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Neoplasm Metastasis Radiation: Novalis Shaped Beam Surgery

Study Design

Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases
Actual Study Start Date : January 14, 2009
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
brain tissue

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated at the University of Rochester Medical Center
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904553


Locations
United States, New York
Department of Radiation Oncology, University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Michael Milano, MD PhD Department of Radiation Oncology, University of Rochester Medical Center
More Information

Responsible Party: Michael Milano, MD,PhD, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00904553     History of Changes
Other Study ID Numbers: URBT07099
RSRB00023405 ( Other Identifier: Univ of Rochester IRB )
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Milano, MD,PhD, University of Rochester:
Brain
metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes