Preoperative chemoradiation in locally resectable adenocarcinoma of pancreatic head without metastasis

Completed

• Conditions: ocally resectable adenocarcinoma of pancreatic head; Cancer; Pancreatic cancer

• Registration Number: ISRCTN78805636
• Lead Sponsor: Friedrich-Alexander University Erlangen-Nuremberg - Medical Faculty (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 254

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median survival of patients from time of randomisation.

Secondary Outcome Measures

Name	Time	Method
1. Three year survival rate<br>2. R0-resection rate<br>3. Rate of medium and high toxicity events (common toxicity criteria)<br>4. Rate of complete and incomplete remission of the tumour in radiographic imaging studies<br>5. Rate of different regression gradings in resected tumour specimens<br>6. Quality of life before/during and after therapy