ISRCTN96397434已完成3 期

European Study Group for Pancreatic Cancer (ESPAC) - Trial 4: combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer

niversity of Liverpool and the Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)0 个研究点目标入组 730 人开始时间: 2008年2月8日最近更新: 2022年11月7日

适应症

试验速览

•1. Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection)
•2. Completion of all pre-operative investigations
•3. Histological confirmation of the primary diagnosis
•4. Histological examination of all resection margins
•5. No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs - CT scan within 3 months prior to randomisation
•6. A World Health Organization performance status less than 2
•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
•10. Life expectancy greater than 3 months
•11. No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix)
•12. No serious medical or psychological condition precluding adjuvant treatment
•13. Fully informed written consent given

•1. Use of neo-adjuvant chemotherapy or other concomitant chemotherapy
•2. Patients with pancreatic lymphoma
•3. Macroscopically remaining tumour (R2 resection)
•4. Patients with Tumor-Node-Metastasis (TNM) Stage IVb disease
•5. Patients younger than 18 years
•6. Pregnancy
•7. New York Heart Association Classification Grade III or IV
•8. Previous chemotherapy
•9. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom
•10. Patients with known malabsorption

发起方

niversity of Liverpool and the Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)