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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose intensified | Experimental | hypofractionated 12x3 Gy + integrated boost 12x4 Gy |
|
| standard | Active Comparator | hypofractionated 10x3 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofractionated 12x3 Gy + integrated boost 12x4 Gy | Radiation | hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT & hfSRT |
| Measure | Description | Time Frame |
|---|---|---|
| tumor control (time up to progression) | up to progression (MR-imaging), max. 5 years after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| severity of acute and chronic adverse effects | acute: assessment up to 6 weeks after therapy; chronic: assessment up to 60 months after therapy or up to progression | |
| overall survival | assessment 60 months after therapy or up to death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Semrau, MD | Contact | ++49(0)9131 85 | 33968 | sabine.semrau@uk-erlangen.de |
| Rainer Fietkau, MD | Contact | ++49(0)9131 85 | 33968 | st-studiensekretariat@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Sabine Semrau, MD | Strahlenklinik, Universitätsklinikum Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
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| hypofractionated 10x3 Gy | Radiation | hypofractionated, homogeneous radiation (10x3 Gy) |
|
| pain control | by visual analog scala and questionnaires according pain | assessment 60 months after therapy |
| Universitätsklinikum Frankfurt; Strahlentherapie | Recruiting | Frankfurt/M. | 60590 | Germany |
| Universitätsklinikum Regensburg, Strahlentherapie | Recruiting | Regensburg | 93053 | Germany |