Plain English Summary
Not provided at time of registration
Trial website
http://www.chirurgie.med.uni-erlangen.de/frames/f_forschung.htm
Contact information
Type
Scientific
Primary contact
Prof Werner Hohenberger
ORCID ID
Contact details
Director
Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
Erlangen
91054
Germany
+49 (0)9131 85 33201
werner.hohenberger@chir.imed.uni-erlangen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00335543
Protocol/serial number
70-3046-Ho 2
Study information
Scientific title
Acronym
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Locally resectable adenocarcinoma of pancreatic head
Intervention
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.
Intervention type
Drug
Phase
Phase II
Drug names
Cisplatin, gemcitabine
Primary outcome measure
Median survival of patients from time of randomisation.
Secondary outcome measures
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
Overall trial start date
23/06/2003
Overall trial end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
254
Participant 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
Recruitment start date
23/06/2003
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Austria, Germany, Switzerland
Trial participating centre
Director
Erlangen
91054
Germany
Sponsor information
Organisation
Friedrich-Alexander University Erlangen-Nuremberg - Medical Faculty (Germany)
Sponsor details
Prof. Dr. W. Hohenberger
Director
Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
Erlangen
91054
Germany
+49 (0)9131 8533201
werner.hohenberger@chir.imed.uni-erlangen.de
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
German Cancer Aid (Deutsche Krebshilfe) (Germany) (ref: 70-3046-Ho 2)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Protocol
Brunner TB, Grabenbauer GG, Meyer T, Golcher H, Sauer R, Hohenberger W, 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)., BMC Cancer, 2007, 7, 41, doi: 10.1186/1471-2407-7-41.
-
Results
Golcher H, Brunner T, Grabenbauer G, Merkel S, Papadopoulos T, Hohenberger W, Meyer T, Preoperative chemoradiation in adenocarcinoma of the pancreas. A single centre experience advocating a new treatment strategy., Eur J Surg Oncol, 2008, 34, 7, 756-764, doi: 10.1016/j.ejso.2007.11.012.
-
Results
Golcher H, Brunner TB, Witzigmann H, Marti L, Bechstein WO, Bruns C, Jungnickel H, Schreiber S, Grabenbauer GG, Meyer T, Merkel S, Fietkau R, Hohenberger W, Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer : Results of the first prospective randomized phase II trial., Strahlenther Onkol, 2014, doi: 10.1007/s00066-014-0737-7.