Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation

Study Overview
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Brief Summary
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The aim of the study is to determine if single fraction dose escalated palliative radiotherapy results in a prolonged duration of benefit for patients otherwise suitable for Multifraction (5-10#) palliative radiation. The primary endpointis to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 12 months post treatment

Detailed Description
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One third of patients treated in the radiation oncology department are treated with palliative intent. These patients are usually unwell due to their advanced disease and suffering from pain and other symptoms related to bony and soft tissue metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients. A meta-analysis of 29 randomised controlled trials (RCTs) estimated the overall response rate (ORR) following RT for bone metastases at approximately 60% with up to one quarter of patients experiencing a complete response (CR). However, palliative patients form a diverse group of patients and selecting the optimal number of palliative treatments which provides an enduring benefit while not being burdensome for the patient can be challenging. The ideal treatment is one that provides lasting symptom control and involves the least number of treatments. Up to one quarter of patients with advanced cancer who undergo palliative RT will die within 1 month of the treatment, while up to 50% of palliative patients will be alive at 12 months . In patients who receive a single fraction of 8Gy, up to 20% of these patients require retreatment to the same site, compared with 8% who receive multiple fraction treatment . One potential option to increase the duration of local control is with hypofractionated, dose escalated radiation.A phase II non-inferiority study investigated this hypothesis in non-spine bone metastases, comparing a single treatment of 12Gy to 30Gy in 10 fractions. The cohort reported a higher pain response in the single fraction dose escalated arm as early as 2 weeks post treatment (62 vs 32%), which was maintained at 9 months (77% vs 46% respectively).

Official Title
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Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation

Conditions
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Palliative Radiotherapy

Intervention / Treatment
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* Radiation: dose escalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic cancer Recommended for 5-10 fractions palliative radiation Patients with spinal cord compression are eligible for enrolment Exclusion Criteria: Unwilling or unable to give informed consent Patients who are recommended for single fraction palliative radiation
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
Interventional Model Description: Non Comparative Randomised Trial Randomised between standard dose multifractions (5-10#) and single fraction dose escalated palliative radiation therapy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard<br>standard radiotherapy 5 fractions | Radiation: dose escalation<br>* single fraction dose escalation to the tumour<br>|
| Experimental: single fraction dose escalation<br>8Gy to Planned Target Volume, 12Gy to Clinical Target Volume +/- 14Gy to Gross Target Volume | Radiation: dose escalation<br>* single fraction dose escalation to the tumour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| benefit from palliative radiotherapy | to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the trial | This will be assessed by the treatment wait time, the amount of time spent in the Radiation Department, the completion rates of electronic Patient Reported Outcome (ePRO)'s and comparing patient and carer assessments | 2 years | 
| Trial Safety | this will be determined by the radiation dose delivered to organs at risk and patient and carer reported toxicity from treatment | 2 years | 
| Efficacy of treatment | Efficacy will be determined by reported treatment benefit, pain response, symptom control,re-treatment rates, overall survival and patient and carer regret | 2 years |