Clinical trial · Interventional
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study
NCT04128332CI-TRIAL-00108786PORTICO-SABRcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-operative stereotactic ablative body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Stereotactic ablative radiotherapy (SABR)
- description
- Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days.
- interventionNames
- Radiation: Pre-operative stereotactic ablative body radiotherapy
Primary outcomes (1)
- measure
- The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days.
- timeFrame
- Up to 30days post surgery
- description
- Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery
Secondary outcomes (5)
- measure
- Measure of surgical resection margin status following pre-operative SABR and immediate surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.