N/A
N=40
Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
Metastatic Cancer · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT00983359 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status — 5 patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status |
5 | — |
| SECONDARY Progression-free Survival (PFS) |
11 | — |
| SECONDARY Time to Neurological Death |
13 | — |
| SECONDARY Time to Systemic Death |
16 | — |
| SECONDARY Karnofsky Decay Time |
14 | — |
Summary
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases
Eligibility Criteria
Inclusion Criteria
- Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.
- Have cancer not originating in central nervous system (CNS)
- Karnofsky score of at least 60
- Given written consent
- At least 18 years of age
Exclusion Criteria
- Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.
- Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
Data sourced from ClinicalTrials.gov (NCT00983359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.