SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Efficacy of palliation using the short course scheme compared with the standard scheme
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
standard treatment
Patients in this group are treated with 3000 cGy in 10 daily fractions
Intervention: standard treatment (Radiation)
short course treatment
Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Intervention: short course treatment (Radiation)
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)
Investigators
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna