European studies group for pancreatic cancer trial 4 Combination versus single agent chemotherapy in resectable pancreatic ductal and peri-ampullary cancers - ESPAC4

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection).
•Patients who have undergone complete macroscopic resection for peri-ampullary carcinoma (R0 or R1 resection).
•Completion of all pre-operative investigations.
•Histological confirmation of the primary diagnosis.
•2) Histological examination of all resection margins.
•3) Patients randomised ideally within 12 weeks of surgery, although case by case the CI will consider patients up to 14 weeks, and can begin treatment ideally within 14 weeks of surgery.
•4)No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs â?? CT (chest, abdomen, pelvis) scan within 3 months prior to randomisation.
•5) A WHO performance status < 2
•6) Creatinine clearance >= 50ml/min(according to Cockcroft and Gaultor equivalent value following local practice).
•7) Fully recovered from the operation and fit to take part in the trial.
•8) Able to attend for administration of the adjuvant therapy.
•9)Able to attend for long-term follow-up.
•Life expectancy > 3 months.
•10) No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).
•11)No serious medical or psychological condition precluding adjuvant treatment.
•12) Fully informed written consent given.

•1)Use of neo-adjuvant chemotherapy or other concomitant chemotherapy.
•2)Patients with pancreatic lymphoma.
•Macroscopically remaining tumour (R2 resection).
•3)Patients with TNM Stage IV disease.
•4)Patients younger than 18 years.
•5)Pregnancy.
•6) New York Heart Association Classification Grade III or IV.
•7)Previous chemotherapy.
•8)All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
•9)Patients with known malabsorption.
•10)Patients with a baseline neutrophil count of <1.5 x 109/l.
•Patients with a baseline platelet count of <100 x 109/l.
•11)Patients with severe hepatic impairment.

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