Welcome
Support Centre
23 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Preoperative chemoradiation in locally resectable adenocarcinoma of pancreatic head without metastasis
ISRCTN ISRCTN78805636
DOI 10.1186/ISRCTN78805636
ClinicalTrials.gov identifier NCT00335543
EudraCT number
Public title Preoperative chemoradiation in locally resectable adenocarcinoma of pancreatic head without metastasis
Scientific title
Acronym N/A
Serial number at source 70-3046-Ho 2
Study hypothesis Aim of the study is to investigate if preoperative chemoradiation is better than immediate surgery regarding median survival for patients with local resectable adenocarcinoma of the pancreatic head without metastasis.
Lay summary Not provided at time of registration
Ethics approval Approval received from the local medical ethics committee (Ethik-Kommission der Medizinischen Fakultat der Friedrich-Alexander-Universitat Erlangen-Nurnberg) on 28/12/2001 (followed by further letters: 21/01/2002, 19/08/2003, 27/07/2004, 11/07/2005).
Study design Randomised controlled open multicentre trial
Countries of recruitment Austria, Germany, Switzerland
Disease/condition/study domain Locally resectable adenocarcinoma of pancreatic head
Participants - 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
Participants - 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
Anticipated start date 23/06/2003
Anticipated end date 30/06/2009
Status of trial Completed
Patient information material
Target number of participants 254
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 weeks later: radiotherapy with single doses of 1.8 Gy on day one to five for five weeks (total dose of 50.4 Gy for tumour and surrounding lymph nodes) and three further doses only for the tumour (total dose 55.8 Gy). Gemcitabine intravenously (iv) 300 mg/m^2 body surface area and cisplatin iv 30 mg/m^2 body surface area on day one, eight, 22, and 29.

Amendment July 11 2005: All resected patients should now receive adjuvant chemotherapy for example gemcitabine 1000 mg/m^2 on day one, eight, 15 (one cycle day 1-28) for six months. NB: it is not the aim of the study to investigate the need of adjuvant chemotherapy.
Primary outcome measure(s) Median survival of patients from time of randomisation.
Secondary outcome measure(s) 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
Sources of funding German Cancer Aid (Deutsche Krebshilfe) (Germany) (ref: 70-3046-Ho 2)
Trial website http://www.chirurgie.med.uni-erlangen.de/frames/f_forschung.htm
Publications 2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17338829
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18191528
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25252602
Contact name Prof  Werner  Hohenberger
  Address Director
Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
  City/town Erlangen
  Zip/Postcode 91054
  Country Germany
  Tel +49 (0)9131 85 33201
  Fax +49 (0)9131 85 36595
  Email werner.hohenberger@chir.imed.uni-erlangen.de
Sponsor Friedrich-Alexander University Erlangen-Nuremberg - Medical Faculty (Germany)
  Address Prof. Dr. W. Hohenberger
Director
Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
  City/town Erlangen
  Zip/Postcode 91054
  Country Germany
  Tel +49 (0)9131 8533201
  Fax +49 (0)9131 8536595
  Email werner.hohenberger@chir.imed.uni-erlangen.de
Date applied 17/01/2005
Last edited 26/09/2014
Date ISRCTN assigned 19/04/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.