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Completed

NCT Number: NCT04128332

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

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addenbrookes Hospital

Cambridge, Cb2 0QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    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

Secondary outcomes

  1. Measure of surgical resection margin status following pre-operative SABR and immediate 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

  2. Measure of local control post SABR and surgery

    Time frame: 1 year

    Number of patients with local control from CT scans up to 12months from the start of SABR

  3. Measure of disease-free survival post SABR and surgery

    Time frame: 1 year

    Number of patients with disease progression from CT scans up to 12months from the start of SABR

  4. Measure of overall survival post SABR and surgery

    Time frame: 1 year

    Number of deaths up to 12 months from the start of SABR treatment

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

    Time frame: 1 year

    Number of adverse events reported up to 12 months from the start of SABR treatment

Sponsors and collaborators

Lead sponsor

CCTU- Cancer Theme

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: PORTICO-SABR

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2019
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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