A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.
This is a single-centre, prospective, non-randomised feasibility study. This study will assess whether SABR can safely be given immediately prior to Whipple's resection by assessing the rate of post-operative complications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Stereotactic ablative body radiotherapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumour, while limiting the dose to the surrounding tissues.
Addenbrookes Hospital
Cambridge, United Kingdom
The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days.
Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery
Time frame: Up to 30days post surgery
Measure of surgical resection margin status following pre-operative SABR and immediate surgery
Measure of Resection margin status (R0 complete resection, R1 microscopic residual tumour, R2 macroscopic residual tumour) from the post surgery histopathology report
Time frame: Post surgery
Measure of local control post SABR and surgery
Number of patients with local control from CT scans up to 12months from the start of SABR
Time frame: 1 year
Measure of disease-free survival post SABR and surgery
Number of patients with disease progression from CT scans up to 12months from the start of SABR
Time frame: 1 year
Measure of overall survival post SABR and surgery
Number of deaths up to 12 months from the start of SABR treatment
Time frame: 1 year
Acute and late toxicity of pre-operative SABR: Number of adverse events
Number of adverse events reported up to 12 months from the start of SABR treatment
Time frame: 1 year
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