This trial is active, not recruiting.

Condition neoplasm metastasis
Treatment novalis shaped beam surgery
Sponsor University of Rochester
Start date March 2008
End date June 2018
Trial size 25 participants
Trial identifier NCT00904553, RSRB00023405, URBT07099


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients with limited brain metastases (mostly solitary brain metastasis) treated with Novalis Shaped Beam Surgery followed by planned craniotomy and resection of the metastases.
novalis shaped beam surgery
Treatment using Novalis SRS

Primary Outcomes

Determine toxicity of treatment with cranial SRS and resection
time frame: 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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases
Principal investigator Michael Milano, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Rochester.