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| [ Print-friendly version ] |
| Preoperative chemoradiation in locally resectable adenocarcinoma of pancreatic head without metastasis |
| ISRCTN | ISRCTN78805636 |
| ClinicalTrials.gov identifier | NCT00335543 |
| 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 | |
| Ethics approval | Approval received from the local medical ethics committee (Ethik-Kommission der Medizinischen Fakultat der Friedrich-Alexander-Universitat Erlangen-Nurnberg) on the 28th December 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 |
Protocol on http://www.ncbi.nlm.nih.gov/pubmed/17338829
Results on http://www.ncbi.nlm.nih.gov/pubmed/18191528 |
| 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 |
| 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 |
| werner.hohenberger@chir.imed.uni-erlangen.de | |
| Date applied | 17/01/2005 |
| Last edited | 09/09/2008 |
| Date ISRCTN assigned | 19/04/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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