Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single

Study Overview
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Brief Summary
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One third of patients treated in the radiation oncology departments are treated with palliative intent. These patients can be unwell due to their advanced disease and suffering from pain and other symptoms related to metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients.The aim of the study is to determine if escalated single fraction palliative radiotherapy using intensity-modulated techniques results in a prolonged duration of benefit for patients otherwise suitable for standard single fraction radiotherapy.

Detailed Description
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Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for palliative patients who can be unwell due to their advanced disease and who suffer from pain and other symptoms related to metastases. A single fraction of 8Gy is considered a standard treatment. In an assessment of health related quality of life (HRQoL) after palliative RT for painful bone metastases, the overall radiotherapy response at 1 week was 45% and by week 2 was 62%. Patients had a significant decrease in pain, insomnia and constipation by 1 month post treatment and an improvement in emotional functioning. When RT is used to control a bleeding tumour, up to 90% of patients will experience haemostasis. There is however concern that 8 Gy in 1 fraction will not provide a durable response, with up to 20% of patients requiring retreatment to the same site, compared with 8% who receive multiple fraction treatment. Single fraction palliative radiation therapy (SFRT) is therefore an under utilised treatment regimen. To implement the higher doses with a single fraction, more advanced radiation techniques are required, and there is still equipoise regarding the benefits. With advances in linear accelerator design and software, it is now possible to treat patients with advanced radiation techniques and low resources. Standard clinical pathways including computer optimised planning, remote (virtual) QA of plan delivery and the use of diagnostic imaging for planning are all feasible (under currently in clinical use at Northern Sydney Cancer Centre). The results from this study will be used to design / proceed to a Randomised Phase III study, if appropriate.

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

Conditions
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Palliative Radiotherapy, Radiotherapy, Intensity-Modulated

Intervention / Treatment
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* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic cancer Recommended for 8Gy/1# palliative radiation Patients with spinal cord compression are eligible for enrolment Exclusion Criteria: Unwilling or unable to give informed consent Patients who are recommended multi 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Arm<br>8 Gy / 1 Fraction | Radiation: Radiation Therapy<br>* Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours<br>|
| Experimental: Single Fraction Dose Escalation<br>8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction | Radiation: Radiation Therapy<br>* Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substantial benefit from palliative radiotherapy | to determine the percentage of patients who 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 |
| --- | --- | --- |
| Treatment Wait Time | The time from the date of the initial consultation and radiation therapy consent to the start date of radiation therapy | 1 week | 
| Radiation Department Time | The time in the radiation oncology department for radiation therapy, from arrival time in the department until the patient is ready for collection at the end of treatment | 1 day | 
| Radiotherapy Treatment Time | The time that the patient is in the Radiation therapy treatment room, from time of entry to time of exit | 1 day | 
| Completion Rates of ePRO's in a Palliative Care Cohort | The rate at which baseline and post treatment questionnaires are completed by both patients and primary carers | 2 years | 
| Comparing Patient and Carer Assessments | Comparing the answers given by patients and carers to determine whether carers can accurately answer on behalf of patients | 2 years | 
| Radiation Doses to Organs at Risk | The radiation doses delivered to the surrounding organs at risk will be reviewed during and after treatment completion to ensure that they meet predefined OAR constraints Patient and carer reported toxicity from treatment | 2 years | 
| Patient Reported Outcomes | Electronic questionnaires delivered to the patient pre-treatment and post treatment at 1, 3, 6, 9, 12, 18, and 24 months. Scores will be calculated in accordance with established scoring methods | 24 months | 
| Carer Reported Outcomes | Electronic questionnaires delivered to the patient's primary carer pre-treatment and post treatment at 1, 3, 6, 9, 12, 18, and 24 months. Scores will be calculated in accordance with established scoring methods | 24 months | 
| Efficacy of treatment | this will be determined by re-treatment rates of irradiated sites, symptom control and recurrence | 2 years | 
| Overall Survival | This will be defined as the time to death measured from the day of randomisation. | 2 years |