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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Neoplasm Metastasis

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Determine toxicity of treatment with cranial SRS and resection

Outcome Time Frame:

During treatment and long term follow-up

Safety Issue:

Yes

Principal Investigator

Michael Milano, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology, University of Rochester Medical Center

Authority:

United States: Institutional Review Board

Study ID:

URBT07099

NCT ID:

NCT00904553

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Neoplasm Metastasis
  • Brain
  • metastases
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

Name

Location

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