Clinical trial NCT04649125: Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation
Official title: Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palliative Radiotherapy
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non Comparative Randomised Trial Randomised between standard dose multifractions (5-10#) and single fraction dose escalated palliative radiation therapy
Primary purpose: TREATMENT

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

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).

Eligibility 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

Primary outcomes:
measure: benefit from palliative radiotherapy
timeFrame: 9 months
Secondary outcomes:
measure: Feasibility of the trial
timeFrame: 2 years
measure: Trial Safety
timeFrame: 2 years
measure: Efficacy of treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Northern Sydney Cancer Centre, Royal North Shore Hospital
name: Thomas Eade
role: PRINCIPAL_INVESTIGATOR
References: