Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Study Overview
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Brief Summary
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Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases

Detailed Description
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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.

Official Title
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SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study

Conditions
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Bone Metastases, Radiotherapy, Palliative Care

Intervention / Treatment
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* Radiation: standard treatment
* Radiation: short course treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard treatment<br>Patients in this group are treated with 3000 cGy in 10 daily fractions | Radiation: standard treatment<br>* 3000 cGy in 10 daily fractions<br>|
| Experimental: short course treatment<br>Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval) | Radiation: short course treatment<br>* 2000 cGy in 4 fractions administered twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of palliation using the short course scheme compared with the standard scheme | Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity in the two treatment groups | incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria | 3 months | 
| Late toxicity in the two treatment groups | incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema | 12 months | 
| Quality of Life (QoL) assessment in the two groups | Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short Course Radiotherapy, Complicated Bone Metastases