Four arm, prospective, multicentre, randomised feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapyfor patients with borderline resectable adenocarcinoma of the pancreas.
- Borderline resectable mass in the pancreatic head as defined by CT criteria (see Table 1).
- Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants).
- Able to undergo biliary drainage using a covered or partially covered self-expanding metal stent.
- Age ≥ 18 years.
- WHO performance status 0, 1.
- Platelets >100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l.
- Serum bilirubin <1.5 ULN.
- Glomerular filtration rate estimated >50ml/min according to Cockcroft & Gault (or equivalent value following local scale/formula).
- Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy.
- Written informed consent.
- Distant metastatic disease.
- Previous or concurrent malignancy diagnoses, except: i) curatively-treated basal cell carcinoma of skin, ii) carcinoma in situ of cervix, iii) previous cancers treated with curative intent, ending treatment ≥ 5 years ago.
- Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection.
- Previous chemotherapy ending < 5 years ago (exceptions may be given case by case by the CI, such as methotrexate for rheumatoid arthritis).
- WHO status 2-4.
- New York Heart Association Classification Grade III or IV.
- Uncontrolled angina/ischaemic heart disease
- Patients with known malabsorption