Advanced Techniques for Single-fraction Palliative Radiotherapy Versus Standard Single Fraction Radiation
Overview
- Phase
- Not Applicable
- Intervention
- Radiation Therapy
- Conditions
- Palliative Radiotherapy
- Sponsor
- Royal North Shore Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Substantial benefit from palliative radiotherapy
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Professor Thomas Eade
Radiation Oncologist
Royal North Shore Hospital
Eligibility Criteria
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
Arms & Interventions
Standard Arm
8 Gy / 1 Fraction
Intervention: Radiation Therapy
Single Fraction Dose Escalation
8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction
Intervention: Radiation Therapy
Outcomes
Primary Outcomes
Substantial benefit from palliative radiotherapy
Time Frame: 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 Outcomes
- Treatment Wait Time(1 week)
- Radiation Department Time(1 day)
- Radiotherapy Treatment Time(1 day)
- Comparing Patient and Carer Assessments(2 years)
- Radiation Doses to Organs at Risk(2 years)
- Patient Reported Outcomes(24 months)
- Carer Reported Outcomes(24 months)
- Completion Rates of ePRO's in a Palliative Care Cohort(2 years)
- Efficacy of treatment(2 years)
- Overall Survival(2 years)