Spots Global Cancer Trial Database for Fractionated Radiosurgery for Painful Spinal Metastases

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Trial Identification

Brief Title: Fractionated Radiosurgery for Painful Spinal Metastases

Official Title: Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)

Study ID: NCT01594892

Conditions

Neoplasm Metastasis

Neoplastic Processes

Neoplasm Recurrence, Local

Neoplasm, Residual

Pain

Interventions

Radiosurgery

Study Description

Brief Summary: 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.

Detailed Description: 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.