Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer (PORTICO-SABR)

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Pancreas
• Intervention / Treatment: Radiation: Pre-operative stereotactic ablative body radiotherapy

Detailed Description

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CCTU- Cancer Theme
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Thankamma Ajithkumar, Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): January 11, 2025
• Study Completion (Actual): January 11, 2025

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PORTICO-SABR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No