Partially Ablative Body Radiotherapy (PABR) for the Palliation of Bulky Tumours

Not Applicable

• Conditions: locally advanced tumours; bulky tumours; unresectable tumours; Cancer - Any cancer

• Registration Number: ACTRN12624000522516
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-26
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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 at or within 2cm from spinal cord
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
Evidence of central necrosis on imaging

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of acute and late toxicities including at least grade 3 treatment related adverse events[Adverse events will be recorded and graded according to CTCAE v5.0. Adverse events will be assessed at every treatment visit, then at weeks 4, 8 and 12 from the start of PABR, then months 6, 9, and 12 from the start of PABR];Changes in laboratory parameters from baseline. [Whole blood sample will be collected from participants to facilitate assessment of laboratory parameters. Laboratory parameters will be assessed at baseline, at the first and last treatment visits, then at weeks 8 and 12 from the start of PABR and then at month 6, 9 and 12 from the start of PABR.];Changes in Eastern Cooperative Oncology Group (ECOG) performance status from baseline. [Clinician assessed via questioning patient on their activities of daily living ECOG will be assessed at baseline, at the first and last treatment visits, then at weeks 8 and 12 from the start of PABR and then at month 6, 9 and 12 from the start of PABR.]