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Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis
This study is currently recruiting participants.
Verified by Tel-Aviv Sourasky Medical Center, June 2007
Sponsored by: Tel-Aviv Sourasky Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00484978
  Purpose

Brain metastases (BM) are the most common intracranial tumors in adults and source of the most common neurological complications of systemic cancer. Surgery and radiation therapy are the most important components in the management of BM with the goal to prolong survival and improve the quality of life. Whole brain radiotherapy (WBRT) has shown to increase local and distant control both with and without surgical resection. However, patients who develop a new or recurrent BM after WBRT and undergo resection are left without adjuvant therapy options. Local recurrence particular in patients with single metastasis does effect both survival and quality of life. In individual cases the option of additional radiotherapy has been suggested and applied. We seek to evaluate the addition of a stereotactic radiosurgery (SRS) boost to the resection cavity both as adjuvant and salvage procedure among patients, who undergo resection of a BM and previously received WBRT or decline WBRT. Goal is to show superior local brain control.


Condition Intervention Phase
Brain Neoplasms
Procedure: Stereotactic Radiosurgery
Phase II

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Single Center Prospective Phase II Study: Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Improved local tumor control after resection [ Time Frame: 6months and 12 months ]

Secondary Outcome Measures:
  • Overall survival Quality of life [ Time Frame: QoL 3-6-12months and overall survival ]

Estimated Enrollment: 35
Study Start Date: February 2007
Estimated Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have undergone surgical resection of a brain metastasis
  • Patients with no more than 3 brain metastases on contrast MRI.
  • Previous WBRT for brain malignancy, except patients with melanoma, renal cell carcinoma.
  • Adult patient aged > 18.
  • Patient must be in adequate general health, as indicated by:

    • Karnofsky performance status equal or greater than 60.
    • The absence of a concomitant life-threatening disease other than the malignancy.
  • Patient must understand the investigational nature of this study and sign informed consent form, approved by the Institutional Review Board.

Exclusion Criteria:

  • Pregnancy
  • Patients unable or unwilling to follow protocol requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484978

Contacts
Contact: Andrew A. Kanner, MD 972-3-6974273 andrewk@tasmc.health.gov.il
Contact: Lina Vizelman 972-3-6974098 linav@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Andrew A Kanner, MD     972-3-6974273     andrewk@tasmc.health.gov.il    
Contact: Lina Vizelman     972-3-6974098     linav@tasmc.health.gov.il    
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Andrew A Kanner, MD Tel Aviv Medical Center, affiliated Tel Aviv University
  More Information

Study ID Numbers: 07-056 TASMC
Study First Received: June 11, 2007
Last Updated: June 11, 2007
ClinicalTrials.gov Identifier: NCT00484978  
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Stereotactic Radiosurgery
Surgery
Metastatic tumor to brain
radiation
Brain Metastases of all pathologies

Study placed in the following topic categories:
Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009