Locally resectable adenocarcinoma of pancreatic head Cancer Pancreatic cancer
Conditions
Interventions
Treatment A: Operation (Whipple operation, standardised lymph node dissection)
Treatment B: Neoadjuvant chemoradiotherapy with gemcitabine and cisplatin followed by operation (same as treatment A) six
Sponsors
Friedrich-Alexander University Erlangen-Nuremberg - Medical Faculty (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adenocarcinoma of pancreatic head, histologically or cytologically proven, resectable as assessed by computed tomography (CT)-scan (major vessels [V. portae, confluence of V. mesenterica and lienalis, A. mes. sup., Truncus coeliacus, A. lienalis, A. hepatica, V. mes. sup.] maximally enclosed up to 180° by the tumour) 2. No infiltration of extrapancreatic organs (exception: duodenum) 3. Only one peripancreatic lymph node (LN) greater than 1 cm on CT-scan (amendment July 11 2005 - this criterion was removed) 4. No metastasis 5. No peritoneal carcinosis (laparoscopy facultative) 6. Age between 18 and 75 years (amendment July 11 2005 - aged 18 or over) 7. Good performance (Karnofsky-index greater than 60) 8. No previous treatment for carcinoma of pancreas 9. No previous malignant disease (exception: non-melanomatous skin tumour, carcinoma in situ of cervix uteri, malignant disease in complete remission treated only surgically at least ten years ago) 10. No participation in other clinical trial in the last three months before randomisation 11. No liver cirrhosis (Quick greater than 70%, thrombocytes greater than 100,000 mm^3) 12. Serum-creatinine less than 1.5 mg/dl; creatinine-clearance greater than 70 ml/min 14. No severe cardiopulmonal disease or any disease which renders the patient not suitable for one treatment option 15. No human immunodeficiency virus (HIV)-infection 16. No lack of judiciousness 17. Written informed consent by the patient
Exclusion criteria
Exclusion criteria: 1. Ampullary carcinoma (tumours origination from the ampulla, the papilla or at the junction of the ampulla and the papilla) 2. 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) 3. Non-ductal adenocarcinoma of the pancreas (e.g. cystadenocarcinoma, neuroendocrine tumours, etc.) 4. Pregnancy or insufficient contraception 5. Aged less than 18 years 6. Karnofsky performance status less than 70 7. Doubtful understanding or contractual capacity of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median survival of patients from time of randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Three year survival rate 2. R0-resection rate 3. Rate of medium and high toxicity events (common toxicity criteria) 4. Rate of complete and incomplete remission of the tumour in radiographic imaging studies 5. Rate of different regression gradings in resected tumour specimens 6. Quality of life before/during and after therapy | — |
Countries
Austria, Germany, Switzerland
Outcome results
None listed