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Fractionated Radiosurgery for Painful Spinal Metastases (DOSIS)

Primary Purpose

Neoplasm Metastasis, Neoplastic Processes, Neoplasm Recurrence, Local

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Radiosurgery
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Spinal metastases, Vertebral metastases, Radiosurgery, Radiotherapy, Stereotactic body radiotherapy, Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leopoldina Schweinfurt
  • Department of Radiation Oncology, University of Wuerzburg
  • Netherlands Cancer Institute
  • University Hospital Zurich
  • The Royal Marsden Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose intensified SBRT

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients, in whom pain is decreased in response to 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

Local tumor control
At the treated vertebral levels assessed with MRI
Local tumor control
At the treated vertebral levels assessed with CT imaging
Overall survival
Death from any cause
Patient-assessed 5 dimensions of patient's quality-of-life
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
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
Measured with NCI CTCAE v 4.0
Number of patients developing late toxicity
Measured with NCI CTCAE v 4.0

Full Information

First Posted
May 7, 2012
Last Updated
September 2, 2019
Sponsor
Wuerzburg University Hospital
Collaborators
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01594892
Brief Title
Fractionated Radiosurgery for Painful Spinal Metastases
Acronym
DOSIS
Official Title
Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis, Neoplastic Processes, Neoplasm Recurrence, Local, Neoplasm, Residual, Pain
Keywords
Spinal metastases, Vertebral metastases, Radiosurgery, Radiotherapy, Stereotactic body radiotherapy, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Evaluation of the single intervention - dose-intensified SBRT
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose intensified SBRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery
Intervention Description
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery
Primary Outcome Measure Information:
Title
Number of patients, in whom pain is decreased in response to treatment
Description
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
Time Frame
Change in pain from baseline to 3 months post-treatment
Secondary Outcome Measure Information:
Title
Local tumor control
Description
At the treated vertebral levels assessed with MRI
Time Frame
2 years
Title
Local tumor control
Description
At the treated vertebral levels assessed with CT imaging
Time Frame
2 years
Title
Overall survival
Description
Death from any cause
Time Frame
2 years
Title
Patient-assessed 5 dimensions of patient's quality-of-life
Description
Measured with the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems) EuroQol 5-Dimension Questionnaire (EQ-5D) questionnaire
Time Frame
Changes in quality of life from baseline to 3 months post-treatment
Title
Patient-assessed overall health status
Description
Measured with the EuroQol Visual Analog Scale from 0 ("the worst health you can imagine") to 100 (the best health you can imagine")
Time Frame
Changes in quality of life from baseline to 3 months post-treatment
Title
Number of patients developing acute toxicity
Description
Measured with NCI CTCAE v 4.0
Time Frame
Changes from baseline up to 6 weeks post-treatment
Title
Number of patients developing late toxicity
Description
Measured with NCI CTCAE v 4.0
Time Frame
Changes from >6weeks up to 2 years post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established histological diagnosis of a malignant tumour (primary or metastatic) Vertebral metastasis confirmed via biopsy or radiology Pain in the involved spinal region or free of pain under pain medication Fully consenting patients, >18 years old Karnofsky Performance Index ≥60% Good or intermediate life expectancy according to the modified prognostic Mizumoto Score (score ≤ 9) Patient must be able to tolerate fixation systems and 30 minutes treatment time Discussed in interdisciplinary tumour board 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: Short life expectancy according to the modified Mizumoto Sore "Radiosensitive" histologies (i.e. lymphoma, SCLC, multiple myeloma) Non-ambulatory status Progressive neurological symptoms/deficit > 3 involved vertebral levels > 2 treatment sites Spine instability Previous radiotherapy at the involved levels
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Guckenberger, MD
Organizational Affiliation
Department of Radiation Oncology, University of Wuerzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leopoldina Schweinfurt
City
Schweinfurt
Country
Germany
Facility Name
Department of Radiation Oncology, University of Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Netherlands Cancer Institute
City
Amsterdam
Country
Netherlands
Facility Name
University Hospital Zurich
City
Zurich
Country
Switzerland
Facility Name
The Royal Marsden Hospital NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23164174
Citation
Guckenberger M, Hawkins M, Flentje M, Sweeney RA. Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial. BMC Cancer. 2012 Nov 19;12:530. doi: 10.1186/1471-2407-12-530.
Results Reference
background
PubMed Identifier
29499073
Citation
Guckenberger M, Sweeney RA, Hawkins M, Belderbos J, Andratschke N, Ahmed M, Madani I, Mantel F, Steigerwald S, Flentje M. Dose-intensified hypofractionated stereotactic body radiation therapy for painful spinal metastases: Results of a phase 2 study. Cancer. 2018 May 1;124(9):2001-2009. doi: 10.1002/cncr.31294. Epub 2018 Mar 2.
Results Reference
result
PubMed Identifier
31526672
Citation
Mantel F, Sweeney RA, Klement RJ, Hawkins MA, Belderbos J, Ahmed M, Toussaint A, Polat B, Flentje M, Guckenberger M. Risk factors for vertebral compression fracture after spine stereotactic body radiation therapy: Long-term results of a prospective phase 2 study. Radiother Oncol. 2019 Dec;141:62-66. doi: 10.1016/j.radonc.2019.08.026. Epub 2019 Sep 13.
Results Reference
derived

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Fractionated Radiosurgery for Painful Spinal Metastases

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