SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Brain Metastases
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Efficacy of palliation using the short course scheme compared with the standard scheme
- Last Updated
- 7 years ago
Overview
Brief Summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors
Detailed Description
Standard treatment for brain metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 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
- •symptomatic brain metastases from solid tumors
- •age \> 18 years
- •ECOG performance status 0-3
- •no changes in supportive care in the week before radiotherapy
Exclusion Criteria
- •pregnancy
- •previous 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 initial symptoms after radiotherapy, assessed with Likert scale (weakness, motor disorders, cognitive impairment, personality changes, loss of balance, seizures, changes in speech, vision, hearing, memory problems, nausea or vomiting are evaluated as none-mild-moderate-severe)
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)