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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00484978
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00484978     History of Changes
Other Study ID Numbers: 07-056 TASMC
Study First Received: June 11, 2007
Last Updated: June 11, 2007
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

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

ClinicalTrials.gov processed this record on August 28, 2014