Spinal Metastases
Conditions
Keywords
spinal metastases, vertebral body, stereotaxis, image-guided radiotherapy, hypofractionated, dose intensified, dose elevation
Brief 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 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.
Interventions
RADIATIONhypofractionated 12x3 Gy + integrated boost 12x4 Gy
hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT & hfSRT
RADIATIONhypofractionated 10x3 Gy
hypofractionated, homogeneous radiation (10x3 Gy)
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor control (time up to progression) | up to progression (MR-imaging), max. 5 years after therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | assessment 60 months after therapy | by visual analog scala and questionnaires according pain |
Countries
Germany
Contacts
Primary ContactSabine Semrau, MD
Backup ContactRainer Fietkau, MD
Outcome results
None listed