NCT03503682
Unknown
N/A
SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study
IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country82 target enrollmentNovember 8, 2017
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bone Metastases
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Efficacy of palliation using the short course scheme compared with the standard scheme
- Last Updated
- 8 years ago
Overview
Brief Summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases
Detailed Description
Standard treatment for complicated bone metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (4000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme.
Investigators
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
Inclusion Criteria
- •complicated bone metastases from any solid tumor
- •age \>18 years
- •ECOG performance status 0-3
- •symptomatic lesion (NRS \>1)
- •no changes in analgesic treatment at least in the week before radiotherapy
Exclusion Criteria
- •pregnancy
- •previously irradiation of the same region
Outcomes
Primary Outcomes
Efficacy of palliation using the short course scheme compared with the standard scheme
Time Frame: 3 months
Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)
Secondary Outcomes
- Acute toxicity in the two treatment groups(3 months)
- Late toxicity in the two treatment groups(12 months)
- Quality of Life (QoL) assessment in the two groups(12 months)
Study Sites (1)
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