Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer

Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study

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.

Inclusion Criteria Stage 1:

• Have given written informed consent to participate in stage 1
• Be aged 16 years or over at the time of signing the informed consent form
• Presence of a hypodense pancreatic mass on contrast enhanced CT scan highly suspicious of operable primary pancreatic cancer as assessed by a pancreatic multi-disciplinary team (MDT)
• Have not had pre-operative systemic therapy or radiotherapy

Inclusion Criteria Stage 2:

• Have participated in stage 1 of the study
• Have confirmed histological or cytological diagnosis of primary pancreatic adenocarcinoma OR radiological evidence of pancreatic head mass with supportive cytological or histological findings.
• Be scheduled to undergo pancreatico-duodenectomy (Whipple's) resection.
• Written informed consent to participate in stage 2
• Aged 16 years or over at the time of signing informed consent
• Have not had pre-operative systemic therapy or radiotherapy
• ECOG Performance status 0-1
• Adequate renal function: GFR ≥ 60

Exclusion Criteria:

• Any condition or abnormalities that in the judgement of the investigator/surgeon/clinical oncologist would place the patient at undue risk
• Women who are known to be pregnant
• Previous abdominal radiotherapy
• Women of child-bearing potential who are unwilling to use 2 highly effective forms of contraception during the study treatment period