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Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis

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ClinicalTrials.gov Identifier: NCT00484978
Recruitment Status : Unknown
Verified June 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : June 12, 2007
Last Update Posted : June 12, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Brain Neoplasms Procedure: Stereotactic Radiosurgery Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center Prospective Phase II Study: Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis
Study Start Date : February 2007
Estimated Study Completion Date : June 2007
Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00484978     History of Changes
Other Study ID Numbers: 07-056 TASMC
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: June 12, 2007
Last Verified: June 2007

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases