Neoplasm MetastasisDOSISNCT01594892
Fractionated Radiosurgery for Painful Spinal Metastases
A study testing Radiosurgery in people with Neoplasm Metastasis and Neoplastic Processes, run by Wuerzburg University Hospital at 5 sites in 4 countries.
Trial summary
It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neoplasm Metastasis, Neoplastic Processes, Neoplasm Recurrence, Local
- What is being tested?
- Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Apr 2012to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
Leopoldina Schweinfurt
Schweinfurt
Department of Radiation Oncology, University of Wuerzburg
Würzburg, 97080
United Kingdom1 site
The Royal Marsden Hospital NHS Foundation Trust
Sutton, SM2 5PT
About this study
Official title: Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)
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.
Read the 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.
- Conditions
- Neoplasm Metastasis, Neoplastic Processes, Neoplasm Recurrence, Local, Neoplasm, Residual, Pain
- Being tested
- Radiosurgery
- Keywords
- Spinal metastases, Vertebral metastases, Radiosurgery, Radiotherapy, Stereotactic body radiotherapy, Pain
- Medical subject headings
- Neoplasm Metastasis, Neoplastic Processes, Neoplasm Recurrence, Local, Neoplasm, Residual, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiosurgeryRadiation
Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery
| Study group | Role | What they receive |
|---|---|---|
| Dose intensified SBRT | Experimental | 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. Receives: Radiation: Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change in pain from baseline to 3 months post-treatment
Secondary outcomes (7)
Local tumor control
At the treated vertebral levels assessed with MRI
Measured: 2 years
Local tumor control
At the treated vertebral levels assessed with CT imaging
Measured: 2 years
Overall survival
Death from any cause
Measured: 2 years
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
Measured: Changes in quality of life from baseline to 3 months post-treatment
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")
Measured: Changes in quality of life from baseline to 3 months post-treatment
Number of patients developing acute toxicity
Measured with NCI CTCAE v 4.0
Measured: Changes from baseline up to 6 weeks post-treatment
Number of patients developing late toxicity
Measured with NCI CTCAE v 4.0
Measured: Changes from >6weeks up to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2015
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluation of the single intervention - dose-intensified SBRT
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, MD, Principal investigator, Department of Radiation Oncology, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594892
- Sponsor's protocol ID
- DOSIS
- Acronym
- DOSIS
- Status last verified
- Aug 2019
- First submitted
- 7 May 2012
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23164174Guckenberger 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.
PubMed 29499073Mantel 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.
PubMed 31526672
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)
- ClinicalTrials.gov ID
- NCT01594892
- Acronym / sponsor ID
- DOSIS / DOSIS
- Conditions
- Neoplasm Metastasis, Neoplastic Processes, Neoplasm Recurrence, Local, Neoplasm, Residual, Pain
- Keywords
- Spinal metastases, Vertebral metastases, Radiosurgery, Radiotherapy, Stereotactic body radiotherapy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- Apr 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluation of the single intervention - dose-intensified SBRT
| Arm | Type | Receives |
|---|---|---|
| Dose intensified SBRT | Experimental | Radiation: RadiosurgeryDepending 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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%
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiosurgeryFractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery | Radiation | Dose intensified SBRT |
Primary outcome
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
7 secondary outcomes
Local tumor control
Time frame: 2 years
Local tumor control
Time frame: 2 years
Overall survival
Time frame: 2 years
Patient-assessed 5 dimensions of patient's quality-of-life
Time frame: Changes in quality of life from baseline to 3 months post-treatment
Patient-assessed overall health status
Time frame: Changes in quality of life from baseline to 3 months post-treatment
Number of patients developing acute toxicity
Time frame: Changes from baseline up to 6 weeks post-treatment
Number of patients developing late toxicity
Time frame: Changes from >6weeks up to 2 years post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Background: PubMed 23164174Guckenberger 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 publication: PubMed 29499073Guckenberger 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.
- Derived from this study: PubMed 31526672Mantel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Guckenberger, MD principal investigator
Department of Radiation Oncology, University of Wuerzburg
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiosurgery in people with Neoplasm Metastasis and Neoplastic Processes, run by Wuerzburg University Hospital at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients, in whom pain is decreased in response to treatment (time frame: Change in pain from baseline to 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594892, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.