Addenbrookes Hospital
Cambridge, Cb2 0QQ, United Kingdom
NCT Number: NCT04128332
A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Cambridge, Cb2 0QQ, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Stage 1:
Inclusion criteria
Stage 2:
Exclusion criteria
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.
Time frame: Up to 30days post surgery
Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery
Time frame: Post 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: 1 year
Number of patients with local control from CT scans up to 12months from the start of SABR
Time frame: 1 year
Number of patients with disease progression from CT scans up to 12months from the start of SABR
Time frame: 1 year
Number of deaths up to 12 months from the start of SABR treatment
Time frame: 1 year
Number of adverse events reported up to 12 months from the start of SABR treatment
CCTU- Cancer Theme
Other
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study
Acronym: PORTICO-SABR
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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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