Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Spinal Metastases

Intervention / Treatment
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* Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy
* Radiation: hypofractionated 10x3 Gy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 geographic reachability of patients Signed study-specific consent form prior to therapy no on-treatment participation on other trials Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dose intensified<br>hypofractionated 12x3 Gy + integrated boost 12x4 Gy | Radiation: hypofractionated 12x3 Gy + integrated boost 12x4 Gy<br>* hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT & hfSRT<br>|
| Active Comparator: standard<br>hypofractionated 10x3 Gy | Radiation: hypofractionated 10x3 Gy<br>* hypofractionated, homogeneous radiation (10x3 Gy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor control (time up to progression) |  | up to progression (MR-imaging), max. 5 years after therapy | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| pain control | by visual analog scala and questionnaires according pain | assessment 60 months after therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal metastases, vertebral body, stereotaxis, image-guided radiotherapy, hypofractionated, dose intensified, dose elevation