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Active, Not Recruiting

NCT Number: NCT04658537

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Palliative Radiotherapy Radiotherapy, Intensity-Modulated

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours

Primary outcomes

  1. 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

  1. Treatment Wait Time

    Time frame: 1 week

    The time from the date of the initial consultation and radiation therapy consent to the start date of radiation therapy

  2. Radiation Department Time

    Time frame: 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

  3. Radiotherapy Treatment Time

    Time frame: 1 day

    The time that the patient is in the Radiation therapy treatment room, from time of entry to time of exit

  4. Completion Rates of ePRO's in a Palliative Care Cohort

    Time frame: 2 years

    The rate at which baseline and post treatment questionnaires are completed by both patients and primary carers

  5. Comparing Patient and Carer Assessments

    Time frame: 2 years

    Comparing the answers given by patients and carers to determine whether carers can accurately answer on behalf of patients

  6. Radiation Doses to Organs at Risk

    Time frame: 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

  7. Patient Reported Outcomes

    Time frame: 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

  8. Carer Reported Outcomes

    Time frame: 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

  9. Efficacy of treatment

    Time frame: 2 years

    this will be determined by re-treatment rates of irradiated sites, symptom control and recurrence

  10. Overall Survival

    Time frame: 2 years

    This will be defined as the time to death measured from the day of randomisation.

Sponsors and collaborators

Lead sponsor

Royal North Shore Hospital

Other

Registry information

Official study title

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

Acronym: ASPIRE single

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Dec 8, 2020
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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