Trials / Completed
CompletedNCT01594892
Fractionated Radiosurgery for Painful Spinal Metastases
Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Wuerzburg University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Radiosurgery | Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2015-07-01
- Completion
- 2017-07-01
- First posted
- 2012-05-09
- Last updated
- 2019-09-04
Locations
5 sites across 4 countries: Germany, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01594892. Inclusion in this directory is not an endorsement.