NCT Number: NCT04649125
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
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Saint Leonards, New South Wales, 2065, Australia
Location status: Recruiting
Carol Kwong, RN
CONTACT
+61294631339 ext. 31339
Heidi Tsang, RN
CONTACT
+61294631340 ext. 31340
Thomas Eade, MBBS
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single fraction dose escalation to the tumour
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
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
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
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
Contact information is provided by the study sponsor or research team.
Royal North Shore Hospital
Other
Acronym: ASPIRE_Multi
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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