We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04658537
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04658537
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Professor Thomas Eade, Royal North Shore Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Palliative Radiotherapy Radiotherapy, Intensity-Modulated Radiation: Radiation Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non Comparative Randomised Trial
Masking: Single (Investigator)
Masking Description: Treatment arm will be masked to investigators. Participants will not be masked.
Primary Purpose: Treatment
Official Title: Advanced Techniques for Single-fraction Palliative Radiotherapy Versus Standard Single Fraction Radiation
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : May 29, 2023
Estimated Study Completion Date : May 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Active Comparator: Standard Arm
8 Gy / 1 Fraction
Radiation: Radiation Therapy
Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours

Experimental: Single Fraction Dose Escalation
8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction
Radiation: Radiation Therapy
Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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): NCT04658537


Contacts
Layout table for location contacts
Contact: Dylan J Chin +612 9463 1337 ext 31337 dylan.chin@health.nsw.gov.au
Contact: Carolyn Kwong, RN +612 9463 1339 ext 31339 Carolyn.Kwong@health.nsw.gov.au

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Thomas Eade Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
Additional Information:
Publications:
Ryu S, Deshmukh S, Timmerman RD, Movsas B, Gerszten PC, Yin FF, et al. Radiosurgery Compared To External Beam Radiotherapy for Localized Spine Metastasis: Phase III Results of NRG Oncology/RTOG 0631. International Journal of Radiation Oncology • Biology • Physics. 2019;105(1):S2-S3.
Wong S, Roderick S, Atyeo JW, Grimberg K, Porter B, Booth J, et al. Improving the Palliative Patient Journey in Radiation Oncology. International Journal of Radiation Oncology • Biology • Physics. 2019;105(1):S49.

Layout table for additonal information
Responsible Party: Professor Thomas Eade, Radiation Oncologist, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT04658537    
Other Study ID Numbers: ASPIRE-single
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results of this trial will be published in a peer reviewed journal. Target journals for publication of this trial include, International Journal of Radiation Oncology Biology Physics

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No