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Fractionated Radiosurgery for Painful Spinal Metastases (DOSIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594892
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Royal Marsden NHS Foundation Trust
Information provided by (Responsible Party):
Wuerzburg University Hospital

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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Neoplastic Processes Neoplasm Recurrence, Local Neoplasm, Residual Pain Radiation: Radiosurgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Evaluation of the single intervention - dose-intensified SBRT
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Radiation: Radiosurgery
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Local tumor control [ Time Frame: 2 years ]
    At the treated vertebral levels assessed with MRI

  2. Local tumor control [ Time Frame: 2 years ]
    At the treated vertebral levels assessed with CT imaging

  3. Overall survival [ Time Frame: 2 years ]
    Death from any cause

  4. 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

  5. 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")

  6. Number of patients developing acute toxicity [ Time Frame: Changes from baseline up to 6 weeks post-treatment ]
    Measured with NCI CTCAE v 4.0

  7. Number of patients developing late toxicity [ Time Frame: Changes from >6weeks up to 2 years post-treatment ]
    Measured with NCI CTCAE v 4.0



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Established histological diagnosis of a malignant tumour (primary or metastatic)
  2. Vertebral metastasis confirmed via biopsy or radiology
  3. Pain in the involved spinal region or free of pain under pain medication
  4. Fully consenting patients, >18 years old
  5. Karnofsky Performance Index ≥60%
  6. Good or intermediate life expectancy according to the modified prognostic Mizumoto Score (score ≤ 9)
  7. Patient must be able to tolerate fixation systems and 30 minutes treatment time
  8. Discussed in interdisciplinary tumour board
  9. The following types of spinal tumours are eligible:

    • Recurrent / residual tumours after surgery
    • Tumours in medically inoperable patients or patients deemed inoperable due to limited life expectancy / tumour load
    • Lesions associated with significant surgical risk

Exclusion Criteria:

  1. Short life expectancy according to the modified Mizumoto Sore
  2. "Radiosensitive" histologies (i.e. lymphoma, SCLC, multiple myeloma)
  3. Non-ambulatory status
  4. Progressive neurological symptoms/deficit
  5. > 3 involved vertebral levels
  6. > 2 treatment sites
  7. Spine instability
  8. Previous radiotherapy at the involved levels

Information from the National Library of Medicine

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


Locations
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Germany
Leopoldina Schweinfurt
Schweinfurt, Germany
Department of Radiation Oncology, University of Wuerzburg
Wuerzburg, Germany, 97080
Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands
Switzerland
University Hospital Zurich
Zurich, Switzerland
United Kingdom
The Royal Marsden Hospital NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Wuerzburg University Hospital
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Matthias Guckenberger, MD Department of Radiation Oncology, University of Wuerzburg
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01594892    
Other Study ID Numbers: DOSIS
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Keywords provided by Wuerzburg University Hospital:
Spinal metastases
Vertebral metastases
Radiosurgery
Radiotherapy
Stereotactic body radiotherapy
Pain
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasm Recurrence, Local
Neoplastic Processes
Neoplasm, Residual
Recurrence
Pathologic Processes
Disease Attributes