ESPAC-5F Studie

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.

 

Einschlusskriterien

• 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.

Ausschlusskriterien

• 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).
• Pregnancy.
• WHO status 2-4.
• New York Heart Association Classification Grade III or IV.
• Uncontrolled angina/ischaemic heart disease
• Patients with known malabsorption