Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single
- Conditions
- Palliative RadiotherapyRadiotherapy, Intensity-Modulated
- Interventions
- Radiation: Radiation Therapy
- Registration Number
- NCT04658537
- Lead Sponsor
- Royal North Shore Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Metastatic cancer
- Recommended for 8Gy/1# palliative radiation
- Patients with spinal cord compression are eligible for enrolment
- Unwilling or unable to give informed consent
- Patients who are recommended multi fraction palliative radiation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Fraction Dose Escalation Radiation Therapy 8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction Standard Arm Radiation Therapy 8 Gy / 1 Fraction
- Primary Outcome Measures
Name Time Method Substantial benefit from palliative radiotherapy 9 months to determine the percentage of patients who achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment.
- Secondary Outcome Measures
Name Time Method Carer Reported Outcomes 24 months 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
Treatment Wait Time 1 week The time from the date of the initial consultation and radiation therapy consent to the start date of radiation therapy
Radiation Department Time 1 day 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
Radiotherapy Treatment Time 1 day The time that the patient is in the Radiation therapy treatment room, from time of entry to time of exit
Comparing Patient and Carer Assessments 2 years Comparing the answers given by patients and carers to determine whether carers can accurately answer on behalf of patients
Radiation Doses to Organs at Risk 2 years 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
Patient Reported Outcomes 24 months 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
Completion Rates of ePRO's in a Palliative Care Cohort 2 years The rate at which baseline and post treatment questionnaires are completed by both patients and primary carers
Efficacy of treatment 2 years this will be determined by re-treatment rates of irradiated sites, symptom control and recurrence
Overall Survival 2 years This will be defined as the time to death measured from the day of randomisation.
Trial Locations
- Locations (1)
Royal North Shore Hospital
🇦🇺Saint Leonards, New South Wales, Australia