ESPAC - 5: European Study Group for Pancreatic Cancer - Trial 5: four arm, prospective, multicentre, randomised feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapy

niversity of Liverpool (UK)0 个研究点目标入组 90 人开始时间: 2014年4月3日最近更新: 2023年1月9日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36521500/ (added 16/12/2022)

•1. Borderline resectable mass in the pancreatic head as defined by CT criteria
•2. Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants)
•3. Able to undergo biliary drainage using a fully covered self expanding metal stent
•4. Age >= 18 years
•5. WHO performance status 0, 1
•6. Platelets >100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l
•7. Serum bilirubin =1.5 ULN
•8. Calculated creatinine clearance > 50ml/min
•9. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy.
•10. Written informed consent; Target Gender: Male & Female ; Lower Age Limit 18 years

•1. Distant metastatic disease
•2. History of previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix)
•3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection
•4. Previous chemotherapy or chemoradiotherapy
•5. Pregnancy
•6. WHO performance status 24
•7. New York Heart Association Classification Grade III or IV
•8. Patients with known malabsorption

发起方

niversity of Liverpool (UK)