Status:
UNKNOWN
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Spinal Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT01849510
Start Date
March 1 2013
End Date
April 1 2019
Last Update
August 11 2017
Active Locations (3)
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1
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
2
Universitätsklinikum Frankfurt; Strahlentherapie
Frankfurt/M., Germany, 60590
3
Universitätsklinikum Regensburg, Strahlentherapie
Regensburg, Germany, 93053