Trial Information
Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial
Inclusion Criteria:
- Painful bone metastasis of solid tumors
- Pain score minimum of 2 on a scale of 10
- A maximum number of painful bone metastases: 3 or more
- Life expectancy > 3 months
- Age minimum 18 years old
- Signed informed consent
Exclusion Criteria:
- Tumor histology (renal cell and melanoma vs. other solid tumors)
- VAS pain score (<5 vs. 6-10).
- Bisphosphonate use (yes vs. no)
- Opioid analgesics (yes vs. no)
- Corticosteroid use (yes vs. no)
- Spine vs non-spine localisation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Level of pain response 1 month after radiotherapy
Outcome Description:
Pain is measured with the visual analogue scale. Response is scored in accordance to the guidelines of the international consensus on palliative radiotherapy.
Outcome Time Frame:
1 month after radiotherapy
Safety Issue:
No
Principal Investigator
Wilfried De Neve, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Ghent
Authority:
Belgium: Ethics Committee
Study ID:
2011/541
NCT ID:
NCT01429493
Start Date:
February 2013
Completion Date:
January 2014
Related Keywords:
- Bone Metastases
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Bone Neoplasms
- Bone Marrow Diseases