Short Course Radiotherapy in Complicated Bone Metastases Palliation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short Course Accelerated Radiation Therapy (Sharon) in Complicated Bone Metastases Palliation

Conditions
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Palliative Care

Intervention / Treatment
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* Radiation: Short course radiotherapy


Participation Criteria
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Eligibility Criteria
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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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short course radiotherapy<br>The radiotherapy is delivered over two days with accelerated hypo-fractionation | Radiation: Short course radiotherapy<br>* An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with complicated bone metastases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Acute toxicity after treatment is evaluated with Common Terminology Criteria for Adverse Events (CTCAE) scale (values from 1 that represents the minimum acute toxicity to 5 that represent the maximum/severe acute toxicity). | 1 year | 
| Quality of life | Quality of life after treatment is evaluated according to Cancer Lineal Analog Scale (CLAS) which evaluated well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one). | 1 year | 
| Pain relief | Pain after the therapy is evaluated with the visual analogically scale (VAS scale). Values range from 0 (no pain) to 10 (worst possible pain). | 1 year | 
| Late toxicity | Late toxicity after treatment is evaluated with Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (EORTC-RTOG scale). The values range from 1 that represents the minimum late toxicity to 5 that represent the maximum/severe late toxicity | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative care, complicated bone metastases, radiotherapy, pain, quality of life