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Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation
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 details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 0 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-05-31
Primary completion: 2025-06-30
Study completion finish: 2025-06-30
Study type
TREATMENT
Phase
NA
Trial ID
NCT04649125
Intervention or treatment
RADIATION: dose escalation
Conditions
- • Palliative Radiotherapy
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
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/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: standard
| RADIATION: dose escalation
|
EXPERIMENTAL: single fraction dose escalation
| RADIATION: dose escalation
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 |
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