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Table 4 Exclusion criteria

From: Primary resection versus neoadjuvant chemoradiation followed by resection for locally resectable or potentially resectable pancreatic carcinoma without distant metastasis. A multi-centre prospectively randomised phase II-study of the Interdisciplinary Working Group Gastrointestinal Tumours (AIO, ARO, and CAO)

• ampullary carcinoma (tumours origination from the ampulla, the papilla or at the junction of the ampulla and the papilla)

• carcinoma of the pancreatic corpus or tail (tumours between the left edge of the superior mesenteric vine and the left edge of the aorta respectively between the left edge of the aorta and the splenic hilum)

• Non-ductal adenocarcinoma of the pancreas (e.g. cystadenocarcinoma, neuroendocrine tumours, etc.)

• Tumour specific prior treatment

• Recurrent tumour

• Peritoneal spread

• distant metastasis

• 2 or more enlarged lymph nodes (> 1 cm), with suspicion of metastatic spread based upon morphology in CT scan.

• Infiltration of extrapancreatic organs except of the duodenum

• vascular involvement > 180° of minimally one of the peripancreatic major vessels (portal vein, confluent of V. mesenterica sup. and V. lienalis, A. mesenterica superior, coeliac trunk, V. mesenterica superior), stenosis or occlusion of one of the mentioned vessels. Resectability only if vascular resection is performed (including portal vein and superior mesenteric vein).

• Prior or synchronous malign neoplasia (Except: non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix and tumour treated by surgery alone with 10 years of disease-free survival)

• Participation at a clinical trial within the last three months prior to inclusion

• Hepatic cirrhosis with platelets < 100 000/mm3 or PTT < 70%

• Serum creatinine > 1.5 mg/dl, creatinine-clearance < 70 ml/min (24 h collection of urine; because of planned chemotherapy with cisplatin)

• Severe cardio-pulmonary concomitant disease (cardiac insufficiency NYHA III/IV, arrhythmia Lown III/IV, pathologic findings at cardiac ultrasound (pathologic ejection fraction), respiratory global insufficiency, or any other severe disease that could interfere with complete therapy as rated by the surgeons or radiation oncologists who participate in the treatment

• HIV-infection

• pregnancy or insufficient contraception

• Age < 18 years

• Karnofsky performance status < 70

• doubtful understanding or contractual capacity of the patient

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BMC Cancer

ISSN: 1471-2407

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