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

niversity of Liverpool0 个研究点目标入组 100 人开始时间: 2016年11月30日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•1. Borderline resectable mass in the pancreatic head as defined by CT criteria (see protocol Table 1).
•2. Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants).
•3. Able to undergo biliary drainage using a covered, partially covered or uncovered 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. Glomerular filtration rate estimated >50ml/min according to Cockcroft & Gault (or equivalent value following local scale/formula).
•9. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy.
•10. Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. Distant metastatic disease.
•2. Previous or concurrent malignancy diagnoses, except curatively-treated (i) basal cell
•carcinoma of skin, ii) carcinoma in situ of cervix; breast; bladder ; (iii) non muscle invasive transitional cell carcinoma of the bladder; iv) previous cancers treated with curative intent, ending treatment = 3 years ago.
•3. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection.
•4. Previous chemotherapy ending < 3 years ago (exceptions may be given case by case by the CI, such as methotrexate for rheumatoid arthritis).
•5. Pregnancy.
•6. WHO status 2-4.
•7. New York Heart Association Classification Grade III or IV.
•8. Uncontrolled Angina/ischaemic heart disease
•9. Patients with known malabsorption.

发起方

niversity of Liverpool