N/A
Completed N=49
Optimal Planning Target Volume With Stereotactic Radiosurgery
Source: ClinicalTrials.gov NCT01017497 ↗Enrolled (actual)
49
Serious AEs
16.3%
Results posted
Oct 2014
Primary outcomePrimary: 12-month Local Control Rate — 91.4; 95.2 percentage of lesions
Summary
The purpose of this study is to estimate the rate of local control at the treated site of the metastasis as a function of 1mm versus 3mm expansion about the gross tumor volume (GTV). Each lesion, not each patient will be ranndomized to either the 1mm or 3mm margin with 40 lesions randomized to each arm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12-month Local Control Rate |
91.4; 95.2 | — |
| SECONDARY Rate of Radionecrosis at SRS Treatment Site |
0.0278; 0.1515 | — |
| SECONDARY 12 Month Rate of Distant Brain Metastases |
45.7 | — |
| SECONDARY Median Overall Survival |
10.6 | — |
| SECONDARY Quality of Life at 3 Months After SRS as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) |
-3.2; -0.4; 0.6; -1.5; -4.5; -1.3 | — |
| SECONDARY Cognition at 3 Months After SRS as Measured by the Mini-Mental State Exam (MMSE) |
0.3 | — |
| SECONDARY Cognition at 3 Months After SRS as Measured by the Trail Making Test (TMT) |
-1.9; -19.9 | — |
| SECONDARY Rate of Death Due to Neurologic Causes |
0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Age >18 years
- Life expectancy of at least 6 months.
- Karnofsky Performance Score greater than 70
- Graded prognostic assessment (GPA score 0.5 or greater
- 1 to 3 brain metastases unresectable
- Maximum tumor diameter no larger than 4cm
Exclusion Criteria
- Primary lesion with radiosensitive histology (such as: small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma.
- Metastases in the brain stem, pons or medulla or within 5 mm of optic apparatus
- Previous cranial radiation
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01017497). 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. Informational only — not medical advice.