Short Course Radiation Therapy in Palliative Treatment of Brain 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 symptomatic brain metastases from solid tumors

Detailed Description
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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

Official Title
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SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study

Conditions
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Brain 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: 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

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 1800 cGy in 4 fractions administered twice a day (at least 6-8 hours interval) | Radiation: short course treatment<br>* 1800 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 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) | 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 Morbility Scoring Schema | 12 months | 
| Quality of Life (QoL) assessment in the two groups | Changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short Course Radiotherapy, Symptomatic brain metastases