Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation (ASPIRE_Multi)

The aim of the study is to determine if single fraction dose escalated palliative radiotherapy results in a prolonged duration of benefit for patients otherwise suitable for Multifraction (5-10#) palliative radiation. The primary endpointis to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 12 months post treatment

Study Overview

• Status: Recruiting
• Conditions: Palliative Radiotherapy
• Intervention / Treatment: Radiation: dose escalation

Detailed Description

One third of patients treated in the radiation oncology department are treated with palliative intent. These patients are usually unwell due to their advanced disease and suffering from pain and other symptoms related to bony and soft tissue metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients. A meta-analysis of 29 randomised controlled trials (RCTs) estimated the overall response rate (ORR) following RT for bone metastases at approximately 60% with up to one quarter of patients experiencing a complete response (CR). However, palliative patients form a diverse group of patients and selecting the optimal number of palliative treatments which provides an enduring benefit while not being burdensome for the patient can be challenging. The ideal treatment is one that provides lasting symptom control and involves the least number of treatments. Up to one quarter of patients with advanced cancer who undergo palliative RT will die within 1 month of the treatment, while up to 50% of palliative patients will be alive at 12 months . In patients who receive a single fraction of 8Gy, up to 20% of these patients require retreatment to the same site, compared with 8% who receive multiple fraction treatment . One potential option to increase the duration of local control is with hypofractionated, dose escalated radiation.A phase II non-inferiority study investigated this hypothesis in non-spine bone metastases, comparing a single treatment of 12Gy to 30Gy in 10 fractions. The cohort reported a higher pain response in the single fraction dose escalated arm as early as 2 weeks post treatment (62 vs 32%), which was maintained at 9 months (77% vs 46% respectively).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carol Kwong, RN; Phone Number: 31339 +61294631339; Email: carolyn.kwong@health.nsw.gov.au
• Study Contact Backup: Name: Heidi Tsang, RN; Phone Number: 31340 +61294631340; Email: heidi.tsang@health.nsw.gov.au

Study Locations

• Australia
  • New South Wales
    • Saint Leonards, New South Wales, Australia, 2065
      • Recruiting
      • Royal North Shore Hospital
      • Contact: Carol Kwong, RN; Phone Number: 31339 +61294631339; Email: carolyn.kwong@health.nsw.gov.au
      • Contact: Heidi Tsang, RN; Phone Number: 31340 +61294631340; Email: heidi.tsang@health.nsw.gov.au
      • Principal Investigator: Thomas Eade, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Metastatic cancer
• Recommended for 5-10 fractions palliative radiation
• Patients with spinal cord compression are eligible for enrolment

Exclusion Criteria:

• Unwilling or unable to give informed consent
• Patients who are recommended for single fraction palliative radiation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard; standard radiotherapy 5 fractions	Radiation: dose escalation; single fraction dose escalation to the tumour
Experimental: single fraction dose escalation; 8Gy to Planned Target Volume, 12Gy to Clinical Target Volume +/- 14Gy to Gross Target Volume	Radiation: dose escalation; single fraction dose escalation to the tumour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
benefit from palliative radiotherapy	to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the trial	This will be assessed by the treatment wait time, the amount of time spent in the Radiation Department, the completion rates of electronic Patient Reported Outcome (ePRO)'s and comparing patient and carer assessments	2 years
Trial Safety	this will be determined by the radiation dose delivered to organs at risk and patient and carer reported toxicity from treatment	2 years
Efficacy of treatment	Efficacy will be determined by reported treatment benefit, pain response, symptom control,re-treatment rates, overall survival and patient and carer regret	2 years

Collaborators and Investigators

• Sponsor: Royal North Shore Hospital
• Collaborators: Northern Sydney and Central Coast Area Health Service
• Investigators: Principal Investigator: Thomas Eade, Northern Sydney Cancer Centre, Royal North Shore Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ASPIRE Multi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The results of this trial will be published in a peer reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No