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

Completed

• Conditions: Neoplasm Metastasis
• Interventions: Radiation: Novalis Shaped Beam Surgery

• Registration Number: NCT00904553
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-14
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Primary Completion: 2022-03-28
• Study Completion: 2022-03-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novalis Shaped Beam Surgery	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.

Primary Outcome Measures

Name	Time	Method
Determine toxicity of treatment with cranial SRS and resection	During treatment and long term follow-up
Determine the local control of the treated lesion(s), distant brain control and overall patient survival.	During treatment and long term follow-up

Secondary Outcome Measures

Name	Time	Method
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.	Following surgical resection

Trial Locations

Locations (1)

Department of Radiation Oncology, University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States