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.
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Spinal Metastases
Both
Spinal Metastases
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
tumor control after 24 months
Outcome Time Frame:
assessment 24 months after therapy
Safety Issue:
No
Principal Investigator
Sabine Semrau, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Strahlenklinik, Universitätsklinikum Erlangen
Authority:
Germany: Ethics Commission
Study ID:
SPIME2013
NCT ID:
NCT01849510
Start Date:
March 2013
Completion Date:
April 2019
Related Keywords:
- Spinal Metastases
- spinal metastases
- vertebral body
- stereotaxis
- image-guided radiotherapy
- hypofractionated
- dose intensified
- dose elevation
- Neoplasm Metastasis
- Neoplasms, Second Primary
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