GliaSite 1-3 Mets Study
This study has been completed.
Sponsor:
Hologic, Inc.
Collaborator:
Methodist Healthcare
Information provided by:
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00589212
First received: December 24, 2007
Last updated: June 9, 2008
Last verified: June 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain Metastases |
Device: GliaSite Radiation Therapy System |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases |
Resource links provided by NLM:
Further study details as provided by Hologic, Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall survival, distant brain recurrence, toxicity and quality of life. [ Time Frame: Survival ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2003 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589212
Locations
| United States, Tennessee | |
| Methodist University Hospital | |
| Memphis, Tennessee, United States, 38104 | |
Sponsors and Collaborators
Hologic, Inc.
Methodist Healthcare
Investigators
| Principal Investigator: | Allen K Sills, Jr., MD | University Hospital |
More Information
No publications provided
| Responsible Party: | Allen K. Sills, Jr. MD, University Hospital |
| ClinicalTrials.gov Identifier: | NCT00589212 History of Changes |
| Other Study ID Numbers: | GS-700 |
| Study First Received: | December 24, 2007 |
| Last Updated: | June 9, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hologic, Inc.:
|
GliaSite Brain metastases 1-3 METS |
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 |
ClinicalTrials.gov processed this record on October 17, 2012
