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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Michael Milano, MD,PhD, University of Rochester
ClinicalTrials.gov Identifier:
NCT00904553
First received: May 15, 2009
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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 Intervention
Neoplasm Metastasis
Radiation: Novalis Shaped Beam Surgery

Study Type: Observational
Study Design: 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

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Determine toxicity of treatment with cranial SRS and resection [ Time Frame: During treatment and long term follow-up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

brain tissue


Estimated Enrollment: 25
Study Start Date: March 2008
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael Milano, MD,PhD, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00904553     History of Changes
Other Study ID Numbers: URBT07099, RSRB00023405
Study First Received: May 15, 2009
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Brain
metastases

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

ClinicalTrials.gov processed this record on September 18, 2014