Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Werner Hohenberger


Contact details

Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
+49 (0)9131 85 33201

Additional identifiers

EudraCT number number


Protocol/serial number

70-3046-Ho 2

Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Locally resectable adenocarcinoma of pancreatic head


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



Phase II

Drug names

Cisplatin, gemcitabine

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

Austria, Germany, Switzerland

Trial participating centre


Sponsor information


Friedrich-Alexander University Erlangen-Nuremberg - Medical Faculty (Germany)

Sponsor details

Prof. Dr. W. Hohenberger
Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
+49 (0)9131 8533201

Sponsor type




Funder type


Funder name

German Cancer Aid (Deutsche Krebshilfe) (Germany) (ref: 70-3046-Ho 2)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results - basic reporting

Publication summary

2007 protocol in:
2008 results in:
2014 results in:

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes