Clinical Trial: Fractionated Radiosurgery for Painful Spinal Metastases

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Wuerzburg University Hospital

Current Primary Outcome: Pain response [ Time Frame: 3 months ]

Pain response 3 months after radiosurgery defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale without analgesic increase will be defined as pain response


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Local tumor control [ Time Frame: 2 years ]
    Local tumor control at the treated vertebral levels and regional tumor control at the neighbouring vertebrae assessed in MRI and CT imaging
  • Overall survival [ Time Frame: 2 years ]
  • Cancer specific mortality [ Time Frame: 2 years ]
  • Quality of life [ Time Frame: 3 months ]
    Quality of life using the EQ-5D and EORTC QLQ-BM22
  • Toxicity [ Time Frame: 2 years ]
    Acute and late toxicity according to NCI CTCAE v 4.0


Original Secondary Outcome: Same as current

Information By: Wuerzburg University Hospital

Dates:
Date Received: May 7, 2012
Date Started: April 2012
Date Completion:
Last Updated: August 6, 2015
Last Verified: August 2015