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

Study Overview
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Brief Summary
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A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.

Detailed Description
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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.

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

Conditions
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Cancer of Pancreas

Intervention / Treatment
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* Radiation: Pre-operative stereotactic ablative body radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stereotactic ablative radiotherapy (SABR)<br>Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days. | Radiation: Pre-operative stereotactic ablative body radiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 30days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 1 year | 
| Measure of overall survival post SABR and surgery | Number of deaths up to 12 months from the start of SABR treatment | 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 | 1 year |