Preoperative chemoradiation in locally resectable adenocarcinoma of pancreatic head without metastasis

ISRCTN	ISRCTN78805636
DOI	https://doi.org/10.1186/ISRCTN78805636
ClinicalTrials.gov (NCT)	NCT00335543
Protocol serial number	70-3046-Ho 2
Sponsor	Friedrich-Alexander University Erlangen-Nuremberg - Medical Faculty (Germany)
Funder	German Cancer Aid (Deutsche Krebshilfe) (Germany) (ref: 70-3046-Ho 2)

Submission date: 17/01/2005
Registration date: 19/04/2005
Last edited: 26/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Werner Hohenberger
Scientific

Director
Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
Erlangen
91054
Germany

Phone	+49 (0)9131 85 33201
Email	werner.hohenberger@chir.imed.uni-erlangen.de

Study information

Primary study design	Interventional
Study design	Randomised controlled open multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Cisplatin, gemcitabine
Primary outcome measure(s)	Median survival of patients from time of randomisation.
Key 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
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	254
Key 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
Key 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
Date of first enrolment	23/06/2003
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Austria
Germany
Switzerland

Study participating centre

Director

Erlangen
91054
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2008		Yes	No
Results article	results	01/01/2015		Yes	No
Protocol article	protocol	06/03/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes