Condition category
Cancer
Date applied
17/01/2005
Date assigned
19/04/2005
Last edited
26/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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

23/06/2003

Overall trial end date

30/06/2009

Reason abandoned

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

Results - basic reporting

Publication summary

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

  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