Kliniken & Institute … Interdisziplinäre… Heidelberger… Für Ärzte Klinische Studien Gastrointestinaltumore … ESPAC

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