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Completed

NCT Number: NCT00589212

GliaSite 1-3 Mets Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GliaSite Radiation Therapy System

Device

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 outcomes

  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 outcomes

  1. Overall survival, distant brain recurrence, toxicity and quality of life.

    Time frame: Survival

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Collaborators

  • Methodist Healthcare - Memphis

Registry information

Official study title

A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Jan 9, 2008
Registry last updated
Jun 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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