Cancer of PancreasPORTICO-SABRNCT04128332
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer
A study testing Pre-operative stereotactic ablative body radiotherapy in people with Cancer of Pancreas, run by CCTU- Cancer Theme at 1 site in United Kingdom.
Trial summary
A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer of Pancreas
- What is being tested?
- Pre-operative stereotactic ablative body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Oct 2020to 11 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Cancer of Pancreas
- Being tested
- Pre-operative stereotactic ablative body radiotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative stereotactic ablative body radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic ablative radiotherapy (SABR) | Other | Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days. Receives: Radiation: Pre-operative stereotactic ablative body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30days post surgery
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 1 year
Measure of overall survival post SABR and surgery
Number of deaths up to 12 months from the start of SABR treatment
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start26 Oct 2020
- Primary completion11 Jan 2025
- Study completion11 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Thankamma Ajithkumar, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128332
- Sponsor's protocol ID
- PORTICO-SABR
- Acronym
- PORTICO-SABR
- Status last verified
- Apr 2026
- First submitted
- 8 Oct 2019
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study
- ClinicalTrials.gov ID
- NCT04128332
- Acronym / sponsor ID
- PORTICO-SABR / PORTICO-SABR
- Conditions
- Cancer of Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 Jan 2025 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic ablative radiotherapy (SABR) | Other | Radiation: Pre-operative stereotactic ablative body radiotherapyStereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative stereotactic ablative body radiotherapyStereotactic 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. | Radiation | Stereotactic ablative radiotherapy (SABR) |
Primary outcome
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
5 secondary outcomes
Measure of surgical resection margin status following pre-operative SABR and immediate surgery
Time frame: Post surgery
Measure of local control post SABR and surgery
Time frame: 1 year
Measure of disease-free survival post SABR and surgery
Time frame: 1 year
Measure of overall survival post SABR and surgery
Time frame: 1 year
Acute and late toxicity of pre-operative SABR: Number of adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thankamma Ajithkumar principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative stereotactic ablative body radiotherapy in people with Cancer of Pancreas, run by CCTU- Cancer Theme at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.