Short Course Accelerated Radiation Therapy (Sharon) in Complicated Bone Metastases Palliation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Palliative Care
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 45
- Primary Endpoint
- Maximum tolerated dose
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with complicated bone metastases.
Detailed Description
The study wants to define the maximum tolerated dose (MTD) of a conformal short course radiation treatment delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of complicated bone metastases.
Investigators
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
Inclusion Criteria
- •radiologically proven complicated bone metastasis
- •age \> 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status \< 3
Exclusion Criteria
- •prior RT to the same region
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: 1 year
The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients
Secondary Outcomes
- Quality of life(1 year)
- Pain relief(1 year)
- Acute toxicity(1 year)
- Late toxicity(1 year)