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

NCT04128332 | Completed

• 1 other identifier: PORTICO-SABR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer of Pancreas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Measure of surgical resection margin status following pre-operative SABR and immediate surgery

  Post surgery

• Measure of local control post SABR and surgery

  1 year

• Measure of disease-free survival post SABR and surgery

  1 year

• Measure of overall survival post SABR and surgery

  1 year

• Acute and late toxicity of pre-operative SABR: Number of adverse events

  1 year

Study Arms (1)

Stereotactic ablative radiotherapy (SABR)

OTHER

Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days.

Radiation: Pre-operative stereotactic ablative body radiotherapy

Interventions

Pre-operative stereotactic ablative body radiotherapy RADIATION

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.

Stereotactic ablative radiotherapy (SABR)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• AstraZeneca: collaborator

Study Sites (1)

Addenbrookes Hospital

Cambridge, Cb2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Thankamma Ajithkumar

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Thankamma Ajithkumar, Consultant Clinical Oncologist

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 16, 2019
• Study Start: October 26, 2020
• Primary Completion: January 11, 2025
• Study Completion: January 11, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)