Clinical trial NCT04658537: Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single
Official title: Advanced Techniques for Single-fraction Palliative Radiotherapy Versus Standard Single Fraction Radiation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palliative Radiotherapy
Radiotherapy, Intensity-Modulated
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non Comparative Randomised Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Substantial benefit from palliative radiotherapy
timeFrame: 9 months
Secondary outcomes:
measure: Treatment Wait Time
timeFrame: 1 week
measure: Radiation Department Time
timeFrame: 1 day
measure: Radiotherapy Treatment Time
timeFrame: 1 day
measure: Completion Rates of ePRO's in a Palliative Care Cohort
timeFrame: 2 years
measure: Comparing Patient and Carer Assessments
timeFrame: 2 years
measure: Radiation Doses to Organs at Risk
timeFrame: 2 years
measure: Patient Reported Outcomes
timeFrame: 24 months
measure: Carer Reported Outcomes
timeFrame: 24 months
measure: Efficacy of treatment
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
name: Thomas Eade
role: PRINCIPAL_INVESTIGATOR
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