Clinical Trials >> Pancreas >> ESPAC-4 >> Eligibility

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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