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CompletedNCT04128332PORTICO-SABRUpdated Apr 20, 2026

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

An interventional study of Pre-operative stereotactic ablative body radiotherapy in Cancer of Pancreas, sponsored by CCTU- Cancer Theme. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by CCTU- Cancer Theme · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
16 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Cancer of Pancreas
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 10 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

CCTU- Cancer Theme is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • RadiationPre-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.

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What researchers measure

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

    Time frame: Up to 30days post surgery

Secondary outcomes

  1. 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

    Time frame: Post surgery

  2. 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

    Time frame: 1 year

  3. 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

    Time frame: 1 year

  4. Measure of overall survival post SABR and surgery

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

    Time frame: 1 year

  5. 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

    Time frame: 1 year

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Study locations

1 site
  • Addenbrookes Hospital
    Cambridge, Cb2 0QQ, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04128332
Lead sponsor
CCTU- Cancer Theme
Collaborators
AstraZeneca
Responsible party
CCTU- Cancer Theme (Dr Thankamma Ajithkumar, Consultant Clinical Oncologist, Cambridge University Hospitals NHS Foundation Trust) — Sponsor-investigator
First posted
Oct 16, 2019
Start date
Oct 26, 2020
Primary completion
Jan 11, 2025
Completion
Jan 11, 2025
Last update
Apr 20, 2026

Study contacts

Thankamma Ajithkumar
principal investigator · Cambridge University Hospitals NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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