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

NCT ID: NCT00904553

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-14
• Study Completion Date: 2022-03-28

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.

Conditions

Neoplasm Metastasis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Novalis Shaped Beam Surgery

Intervention Type: RADIATION

Treatment using Novalis SRS

Interventions

Novalis Shaped Beam Surgery

Treatment using Novalis SRS

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Michael Milano, MD,PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Milano, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, University of Rochester Medical Center

Locations

Department of Radiation Oncology, University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

RSRB00023405

Identifier Type: OTHER

Identifier Source: secondary_id

URBT07099

Identifier Type: -

Identifier Source: org_study_id