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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

Universitätsklinikum Erlangen

Erlangen, Germany, 91054

2

Universitätsklinikum Frankfurt; Strahlentherapie

Frankfurt/M., Germany, 60590

3

Universitätsklinikum Regensburg, Strahlentherapie

Regensburg, Germany, 93053