It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this II trial.
The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study. 1. A prognostic score for overall survival will be used for selection of patients with longer life expectancy to allow for analysis of long-term efficacy and safety. 2. Fractionated radiosurgery will be performed with the number of treatment fractions adjusted to either good (10 fractions) or intermediate (5 fractions) life expectancy. Fractionation will allow inclusion of tumors immediately abutting the spinal cord due to higher biological effective doses at the tumor - spinal cord interface compared to single fraction treatment. 3. Dose intensification will be performed in the involved parts of the vertebrae only, while uninvolved parts are treated with conventional doses using the simultaneous integrated boost concept.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery
Leopoldina Schweinfurt
Schweinfurt, Germany
Department of Radiation Oncology, University of Wuerzburg
Würzburg, Germany
Netherlands Cancer Institute
Amsterdam, Netherlands
University Hospital Zurich
Zurich, Switzerland
Number of patients, in whom pain is decreased in response to treatment
Decrease in pain by ≥2 points at the treated vertebral site on the 0 (no pain) to 10 (the severest pain) Visual Analogue Scale without analgesic increase
Time frame: Change in pain from baseline to 3 months post-treatment
Local tumor control
At the treated vertebral levels assessed with MRI
Time frame: 2 years
Local tumor control
At the treated vertebral levels assessed with CT imaging
Time frame: 2 years
Overall survival
Death from any cause
Time frame: 2 years
Patient-assessed 5 dimensions of patient's quality-of-life
Measured with the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems) EuroQol 5-Dimension Questionnaire (EQ-5D) questionnaire
Time frame: Changes in quality of life from baseline to 3 months post-treatment
Patient-assessed overall health status
Measured with the EuroQol Visual Analog Scale from 0 ("the worst health you can imagine") to 100 (the best health you can imagine")
Time frame: Changes in quality of life from baseline to 3 months post-treatment
Number of patients developing acute toxicity
Measured with NCI CTCAE v 4.0
Time frame: Changes from baseline up to 6 weeks post-treatment
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The Royal Marsden Hospital NHS Foundation Trust
Sutton, United Kingdom
Number of patients developing late toxicity
Measured with NCI CTCAE v 4.0
Time frame: Changes from >6weeks up to 2 years post-treatment