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

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904553
• Other study ID #: URBT07099
• Secondary ID: RSRB00023405
• Status: Completed
• Start date: January 14, 2009
• Est. completion date: March 28, 2022

Study information

• Verified date: May 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Radiation:
• Novalis Shaped Beam Surgery
Treatment using Novalis SRS

Locations

Country	Name	City	State
United States	Department of Radiation Oncology, University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine toxicity of treatment with cranial SRS and resection		During treatment and long term follow-up
Primary	Determine the local control of the treated lesion(s), distant brain control and overall patient survival.		During treatment and long term follow-up
Secondary	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