Spinal MetastasesPhase 2SPIN-METNCT01849510
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
A Phase 2 study testing hypofractionated 12x3 Gy + integrated boost 12x4 Gy and hypofractionated 10x3 Gy in people with Spinal Metastases, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
Trial summary
Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- hypofractionated 12x3 Gy + integrated boost 12x4 Gy and hypofractionated 10x3 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 3 sitesGermany
- Study dates
- Mar 2013to Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- minimum age 18
- expectance of life at least 6 months
- Karnofsky-Score > 50
- 1-3 vertebral body metastases
- Up to 5 other, macroscopic metastases
- effective contraception
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- geographic reachability of patients
- Signed study-specific consent form prior to therapy
- no on-treatment participation on other trials
Who cannot join
- initial required neurosurgical decompression
- rapid, neurological deterioration
- prior radiotherapy of region for planned radiation
- conditions that preclude the application of magnetic resonance tomography
- malignancy: multiple myeloma or lymphoma
- technical conditions preclude stereotactic irradiation (technical limitations of device)
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- pregnant or nursing women
- Fertile patients who refuse effective contraception during study treatment
- persistent drug and/or alcohol abuse
- patients that are not able or willing to behave according to study protocol
- absent attendance for personal, disease related data storage and transfer
- on-treatment participation on other trials
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Universitätsklinikum Erlangen
Erlangen, 91054
Universitätsklinikum Frankfurt; Strahlentherapie
Frankfurt/M., 60590
Universitätsklinikum Regensburg, Strahlentherapie
Regensburg, 93053
About this study
Official title: Efficacy of Dose Intensified Radiotherapy of Spinal Metastases of Solid Tumors by Dose Increased, Homogeneous Radiation of Vertebral Body and Simultaneous Application of Stereotactic Boost.
Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. This trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. Dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT \& hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy). Primary endpoint is local tumor control (time up to progression). Secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. It is planned to recruit a total number of 155 patients.
- Conditions
- Spinal Metastases
- Being tested
- hypofractionated 12x3 Gy + integrated boost 12x4 Gy, hypofractionated 10x3 Gy
- Keywords
- spinal metastases, vertebral body, stereotaxis, image-guided radiotherapy, hypofractionated, dose intensified, dose elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated 12x3 Gy + integrated boost 12x4 GyRadiation
hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT \& hfSRT
hypofractionated 10x3 GyRadiation
hypofractionated, homogeneous radiation (10x3 Gy)
| Study group | Role | What they receive |
|---|---|---|
| dose intensified | Experimental | hypofractionated 12x3 Gy + integrated boost 12x4 Gy Receives: Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy |
| standard | Active comparator | hypofractionated 10x3 Gy Receives: Radiation: hypofractionated 10x3 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor control (time up to progression)
Measured: up to progression (MR-imaging), max. 5 years after therapy
Secondary outcomes (3)
severity of acute and chronic adverse effects
Measured: acute: assessment up to 6 weeks after therapy; chronic: assessment up to 60 months after therapy or up to progression
overall survival
Measured: assessment 60 months after therapy or up to death
pain control
by visual analog scala and questionnaires according pain
Measured: assessment 60 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Semrau, MD, Principal investigator, Strahlenklinik, Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849510
- Sponsor's protocol ID
- SPIME2013
- Acronym
- SPIN-MET
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2013
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dose Intensified Radiotherapy of Spinal Metastases of Solid Tumors by Dose Increased, Homogeneous Radiation of Vertebral Body and Simultaneous Application of Stereotactic Boost.
- ClinicalTrials.gov ID
- NCT01849510
- Acronym / sponsor ID
- SPIN-MET / SPIME2013
- Conditions
- Spinal Metastases
- Keywords
- spinal metastases, vertebral body, stereotaxis, image-guided radiotherapy, hypofractionated, dose intensified, dose elevation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 8 May 2013 (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.
Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. This trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. Dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT \& hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy). Primary endpoint is local tumor control (time up to progression). Secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. It is planned to recruit a total number of 155 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose intensified | Experimental | Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gyhypofractionated 12x3 Gy + integrated boost 12x4 Gy |
| standard | Active comparator | Radiation: hypofractionated 10x3 Gyhypofractionated 10x3 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- minimum age 18
- expectance of life at least 6 months
- Karnofsky-Score > 50
- 1-3 vertebral body metastases
- Up to 5 other, macroscopic metastases
Key exclusion criteria (12 listed)
- initial required neurosurgical decompression
- rapid, neurological deterioration
- prior radiotherapy of region for planned radiation
- conditions that preclude the application of magnetic resonance tomography
- malignancy: multiple myeloma or lymphoma
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 |
|---|---|---|
| hypofractionated 12x3 Gy + integrated boost 12x4 Gyhypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT \& hfSRT | Radiation | dose intensified |
| hypofractionated 10x3 Gyhypofractionated, homogeneous radiation (10x3 Gy) | Radiation | standard |
Primary outcome
tumor control (time up to progression)
Time frame: up to progression (MR-imaging), max. 5 years after therapy
3 secondary outcomes
severity of acute and chronic adverse effects
Time frame: acute: assessment up to 6 weeks after therapy; chronic: assessment up to 60 months after therapy or up to progression
overall survival
Time frame: assessment 60 months after therapy or up to death
pain control
Time frame: assessment 60 months after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Sabine Semrau, MD principal investigator
Strahlenklinik, Universitätsklinikum Erlangen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypofractionated 12x3 Gy + integrated boost 12x4 Gy and hypofractionated 10x3 Gy in people with Spinal Metastases, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
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 9 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
tumor control (time up to progression) (time frame: up to progression (MR-imaging), max. 5 years after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.