Clinical trial · Interventional
GliaSite 1-3 Mets Study
A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
NCT00589212CI-TRIAL-00001530completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GliaSite Radiation Therapy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients with 1-3 brain metastases
- interventionNames
- Device: GliaSite Radiation Therapy System
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 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)
- measure
- Overall survival, distant brain recurrence, toxicity and quality of life.
- timeFrame
- Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.