Fractionated Radiosurgery for Painful Spinal Metastases (DOSIS)
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|ClinicalTrials.gov Identifier: NCT01594892|
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Metastasis Neoplastic Processes Neoplasm Recurrence, Local Neoplasm, Residual Pain||Radiation: Radiosurgery||Not Applicable|
The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study.
- 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.
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Evaluation of the single intervention - dose-intensified SBRT|
|Masking:||None (Open Label)|
|Official Title:||Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2017|
Experimental: Dose intensified SBRT
Depending on the modified Mizumoto Score (0-4 points or 5-9 points) patients will be treated with 10 fractions of 4.85Gy in involved parts of the vertebra and 3Gy in not-involved parts using a simultaneous integrated boost or with 5 fractions of 7Gy in involved parts of the vertebra and 4Gy in not-involved parts using a simultaneous integrated boost, respectively.
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery
- Number of patients, in whom pain is decreased in response to treatment [ Time Frame: Change in pain from baseline to 3 months post-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
- Local tumor control [ Time Frame: 2 years ]At the treated vertebral levels assessed with MRI
- Local tumor control [ Time Frame: 2 years ]At the treated vertebral levels assessed with CT imaging
- Overall survival [ Time Frame: 2 years ]Death from any cause
- Patient-assessed 5 dimensions of patient's quality-of-life [ Time Frame: Changes in quality of life from baseline to 3 months post-treatment ]Measured with the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems) EuroQol 5-Dimension Questionnaire (EQ-5D) questionnaire
- Patient-assessed overall health status [ Time Frame: Changes in quality of life from baseline to 3 months post-treatment ]Measured with the EuroQol Visual Analog Scale from 0 ("the worst health you can imagine") to 100 (the best health you can imagine")
- Number of patients developing acute toxicity [ Time Frame: Changes from baseline up to 6 weeks post-treatment ]Measured with NCI CTCAE v 4.0
- Number of patients developing late toxicity [ Time Frame: Changes from >6weeks up to 2 years post-treatment ]Measured with NCI CTCAE v 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594892
|Department of Radiation Oncology, University of Wuerzburg|
|Wuerzburg, Germany, 97080|
|Netherlands Cancer Institute|
|University Hospital Zurich|
|The Royal Marsden Hospital NHS Foundation Trust|
|Sutton, United Kingdom, SM2 5PT|
|Principal Investigator:||Matthias Guckenberger, MD||Department of Radiation Oncology, University of Wuerzburg|