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

NCT04649125 | Recruiting DMC

• 1 other identifier: ASPIRE Multi
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Palliative Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Feasibility of the trial

  2 years

• Trial Safety

  2 years

• Efficacy of treatment

  2 years

Study Arms (2)

standard

ACTIVE COMPARATOR

standard radiotherapy 5 fractions

Radiation: dose escalation

single fraction dose escalation

EXPERIMENTAL

8Gy to Planned Target Volume, 12Gy to Clinical Target Volume +/- 14Gy to Gross Target Volume

Radiation: dose escalation

Interventions

dose escalation RADIATION

single fraction dose escalation to the tumour

single fraction dose escalation; standard

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Royal North Shore Hospital: lead
• Northern Sydney and Central Coast Area Health Service: collaborator

Study Sites (1)

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

Study Officials

• Thomas Eade

  Northern Sydney Cancer Centre, Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Kwong, RN

CONTACT

+61294631339; carolyn.kwong@health.nsw.gov.au

Heidi Tsang, RN

CONTACT

+61294631340; heidi.tsang@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators do not know which arm patients have been randomised to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non Comparative Randomised Trial Randomised between standard dose multifractions (5-10#) and single fraction dose escalated palliative radiation therapy

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: May 31, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

AU (1)