NCT00904553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

13.2 years

First QC Date

May 15, 2009

Last Update Submit

May 5, 2022

Conditions

Neoplasm Metastasis

Keywords

Brainmetastases

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

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.

Radiation: Novalis Shaped Beam Surgery

Interventions

Novalis Shaped Beam SurgeryRADIATION

Treatment using Novalis SRS

Novalis Shaped Beam Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated at the University of Rochester Medical Center

You may qualify if:

  • 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.

You may not qualify if:

  • KPS\<60
  • life expectancy \> 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

brain tissue

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Milano, MD PhD

    Department of Radiation Oncology, University of Rochester Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 19, 2009

Study Start

January 14, 2009

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)