NCT04658537

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Palliative Radiotherapy
• Radiotherapy, Intensity-Modulated

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours

Timeline

• Start date: 2021-06-29
• Primary completion: 2024-10-04
• Completion: 2026-12-31
• First posted: 2020-12-08
• Last updated: 2026-02-05

Locations

1 site across 1 country: Australia