Clinical trial · Observational
Study of Resection Combined With Stereotactic Radiosurgery for 1 to 3 Brain Metastases
Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases
NCT00904553CI-TRIAL-00058364completedClinicalTrials.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 is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment. The purpose of this study is to determine what side effects are common or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other brain metastases.
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 |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novalis Shaped Beam Surgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Novalis Shaped Beam Surgery
- description
- Patients with limited brain metastases (mostly solitary brain metastasis) treated with Novalis Shaped Beam Surgery followed by planned craniotomy and resection of the metastases.
- interventionNames
- Radiation: Novalis Shaped Beam Surgery
Primary outcomes (2)
- measure
- Determine toxicity of treatment with cranial SRS and resection
- timeFrame
- During treatment and long term follow-up
- measure
- Determine the local control of the treated lesion(s), distant brain control and overall patient survival.
- timeFrame
- During treatment and long term follow-up
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a previously histopathologically proven diagnosis of malignancy. * Patients must be evaluated by Neurosurgery and Radiation Oncology * Patients must have 1-3 brain metastases seen on MRI or CT imaging. At least one brain metastases must be considered resectable by craniotomy as determined by the treating neurosurgeon. Brain lesion resection must be considered standard of care. A not uncommon situation is for a patient to undergo resection of a solitary metastasis, but prove to have more lesions on subsequent MRIs (perhaps too small to be seen on a pre-operative MRI). These patients will be eligible if the total number of lesions is 1-3. * All lesions must be treatable by SRS as determined by the treating neurosurgeon and radiation oncologist. * All lesions must be \<4 cm in greatest dimension. For patients with more than 1 brain metastases, only 1 lesion can exceed 3 cm in greatest dimension. * In patients treated to the post-op surgical cavity, this cavity must be encompassed by a CTV of \<5 cm. * Patients must have a Karnofsky performance status ≥60. * Extracranial disease must not be considered imminently life threatening (\<2 month anticipated survival from extracranial disease). * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * KPS\<60 * life expectancy \> 2 months
References
Publications (0)
Data not yet available
No reference posted for this study.