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Trial record 1 of 1 for:    NCT04649125
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Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation (ASPIRE_Multi)

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ClinicalTrials.gov Identifier: NCT04649125
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Professor Thomas Eade, Royal North Shore Hospital

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

Condition or disease Intervention/treatment Phase
Palliative Radiotherapy Radiation: dose escalation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non Comparative Randomised Trial Randomised between standard dose multifractions (5-10#) and single fraction dose escalated palliative radiation therapy
Masking: Single (Investigator)
Masking Description: Investigators do not know which arm patients have been randomised to
Primary Purpose: Treatment
Official Title: Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation
Actual Study Start Date : May 31, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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




Primary Outcome Measures :
  1. benefit from palliative radiotherapy [ Time Frame: 9 months ]
    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


Secondary Outcome Measures :
  1. Feasibility of the trial [ Time Frame: 2 years ]
    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. Trial Safety [ Time Frame: 2 years ]
    this will be determined by the radiation dose delivered to organs at risk and patient and carer reported toxicity from treatment

  3. Efficacy of treatment [ Time Frame: 2 years ]
    Efficacy will be determined by reported treatment benefit, pain response, symptom control,re-treatment rates, overall survival and patient and carer regret



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649125


Contacts
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Contact: Carol Kwong, RN +61294631339 ext 31339 carolyn.kwong@health.nsw.gov.au
Contact: Heidi Tsang, RN +61294631340 ext 31340 heidi.tsang@health.nsw.gov.au

Locations
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Australia, New South Wales
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia, 2065
Contact: Carol Kwong, RN    +61294631339 ext 31339    carolyn.kwong@health.nsw.gov.au   
Contact: Heidi Tsang, RN    +61294631340 ext 31340    heidi.tsang@health.nsw.gov.au   
Principal Investigator: Thomas Eade, MBBS         
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
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Principal Investigator: Thomas Eade Northern Sydney Cancer Centre, Royal North Shore Hospital
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Responsible Party: Professor Thomas Eade, Radiation Oncologist, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT04649125    
Other Study ID Numbers: ASPIRE Multi
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The results of this trial will be published in a peer reviewed journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No