None listed
Conditions
Brief summary
This study is assessing the safety and efficacy of a new way of delivering radiotherapy, called Partially Ablative Body Radiotherapy (PABR), to tumours that are considered too bulky to treat with curative intent. Who is it for? You may be eligible for this study if you have a confirmed diagnosis of a non-haematologic malignancy not amenable to curative intent treatment, however are a candidate for palliative radiotherapy for a tumour size of at least 5cm. Study details Patients will undergo 5 sessions of radiotherapy on non-consecutive days over 2 weeks. The radiotherapy will be planned to deliver a higher dose to the core of the tumour and a lower, palliative dose to the periphery. Participants will have data collected on treatment related adverse events and tumour response to the radiotherapy, and will be asked to complete questionnaires on outcomes such as pain and quality of life. It is hoped that findings from this study will help develop PABR as a treatment modality for the palliation of bulky tumours.
Interventions
The treatment for this study is partially ablative body radiotherapy (PABR). This technique delivers an ablative dose to the central core of the tumour and a palliative dose to the periphery using simultaneous integrated boost (SIB). Prescribed dose for all patients is 20Gray in 5 fractions with SIB to 50Gy, delivered on non-consecutive days over 2 weeks, at 2-3 visits per week. Each treatment visit may take up to 30 minutes. Treatment will be prescribed by a Radiation Oncologist and delivered a
The treatment for this study is partially ablative body radiotherapy (PABR). This technique delivers an ablative dose to the central core of the tumour and a palliative dose to the periphery using simultaneous integrated boost (SIB). Prescribed dose for all patients is 20Gray in 5 fractions with SIB to 50Gy, delivered on non-consecutive days over 2 weeks, at 2-3 visits per week. Each treatment visit may take up to 30 minutes. Treatment will be prescribed by a Radiation Oncologist and delivered at a radiotherapy centre approved as a study site. Prior to treatment commencing, all participants will be required to attend for a planning CT scan. Participants will be positioned using stabilisation and/or immobilisation equipment to ensure that set-up can be reproduced on each day of treatment. This planning appointment may take 1 hour. To ensure treatment is delivered as planned, a daily online image guidance procedure will be performed. Additionally, the direct observation of PABR administration by the Investigator and site staff will ensure compliance with the protocol requirements. The date and time of each dose and fraction of PABR administered in the clinic will be recorded in the participant’s medical record and study electronic case report form.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically or cytologically confirmed non-haematologic malignancy not amenable to curative intent treatment. Must be a candidate for palliative radiotherapy for a tumour size of at least 5cm as measured by clinical examination or radiologic imaging At least one measurable disease tumour lesion as assessed by investigator per RECIST v1.1 Not suitable for SABR (stereotactic ablative body radiotherapy) or surgery, or has declined surgery
Exclusion criteria
Tumours entering the spinal canal Prior radiotherapy that overlaps with planned site of intervention within 2 years prior to screening Received concurrent cytotoxic or targeted therapy within 3-4 weeks prior to the fraction of PABR, or concurrent use of these therapies during intervention period
Outcome results
None listed