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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 0 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-06-29

    Primary completion: 2024-12-31

    Study completion finish: 2024-12-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04658537

    Intervention or treatment

    RADIATION: Radiation Therapy

    Conditions

    • Palliative Radiotherapy
    • Radiotherapy, Intensity-Modulated
    Image related to Palliative Radiotherapy
    • Condition: Palliative Radiotherapy, Radiotherapy, Intensity-Modulated

    • RADIATION: Radiation Therapy

    • Saint Leonards, New South Wales, Australia

    • Sponsor: Royal North Shore Hospital

    Find a site

    Closest Location:

    Royal North Shore Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal North Shore Hospital

      Saint Leonards, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Substantial benefit from palliative radiotherapyto determine the percentage of patients who achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment.9 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Treatment Wait TimeThe time from the date of the initial consultation and radiation therapy consent to the start date of radiation therapy1 week
    Radiation Department TimeThe 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 treatment1 day
    Radiotherapy Treatment TimeThe time that the patient is in the Radiation therapy treatment room, from time of entry to time of exit1 day
    Completion Rates of ePRO's in a Palliative Care CohortThe rate at which baseline and post treatment questionnaires are completed by both patients and primary carers2 years
    Comparing Patient and Carer AssessmentsComparing the answers given by patients and carers to determine whether carers can accurately answer on behalf of patients2 years
    Radiation Doses to Organs at RiskThe 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 treatment2 years
    Patient Reported OutcomesElectronic 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 methods24 months
    Carer Reported OutcomesElectronic 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 methods24 months
    Efficacy of treatmentthis will be determined by re-treatment rates of irradiated sites, symptom control and recurrence2 years
    Overall SurvivalThis will be defined as the time to death measured from the day of randomisation.2 years

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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    References

    Clinical Trials Gov: Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single

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