GliaSite 1-3 Mets Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00589212
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : June 11, 2008
Methodist Healthcare
Information provided by:
Hologic, Inc.

Brief Summary:
This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.

Condition or disease Intervention/treatment Phase
Brain Metastases Device: GliaSite Radiation Therapy System Phase 2

Detailed Description:
Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
Study Start Date : October 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: 1
Patients with 1-3 brain metastases
Device: GliaSite Radiation Therapy System
GliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity.

Primary Outcome Measures :
  1. The primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy. [ Time Frame: Data collected at the time of implant, within 72 hours of implant, pre-brachytherapy, brachytherapy, radiosurgery, 1 and 3 months post brachytherapy and every 3 months thereafter ]

Secondary Outcome Measures :
  1. Overall survival, distant brain recurrence, toxicity and quality of life. [ Time Frame: Survival ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan
  • Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report
  • Have a Karnofsky Performance Status (KPS) >=70
  • Have systemic disease which is judged to be stable and has been staged within the last 6 weeks
  • Have a life expectancy of >= 6 month, based upon extent of systemic disease
  • Be at least 18 years of age Give informed consent (or have legal representative give informed consent)

Exclusion Criteria:

  • Be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor.
  • Be receiving or have plans to receive external beam radiation therapy to the brain.
  • Have received prior conventional or investigational systemic agents, including the use of Gliadel Wafers or Temodar, for the treatment of the brain metastasis.
  • Be pregnant or breast-feeding.
  • Have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia.
  • Have other serious concurrent infection or other medical illness which would jeopardize the ability of the patient to safely undergo resection and brachytherapy.
  • Have histology of lymphoma or small-cell lung cancer.

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 identifier (NCT number): NCT00589212

United States, Tennessee
Methodist University Hospital
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Hologic, Inc.
Methodist Healthcare
Principal Investigator: Allen K Sills, Jr., MD University Hospital

Responsible Party: Allen K. Sills, Jr. MD, University Hospital Identifier: NCT00589212     History of Changes
Obsolete Identifiers: NCT00096252
Other Study ID Numbers: GS-700
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: June 11, 2008
Last Verified: June 2008

Keywords provided by Hologic, Inc.:
Brain metastases
1-3 METS

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