Pain Clinical Trial
Official title:
Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)
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.
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