Preoperative chemoradiation in locally resectable adenocarcinoma of pancreatic head without metastasis
| ISRCTN | ISRCTN78805636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78805636 |
| ClinicalTrials.gov number | NCT00335543 |
| Secondary identifying numbers | 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
Scientific
Director
Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
Erlangen
91054
Germany
| Phone | +49 (0)9131 85 33201 |
|---|---|
| werner.hohenberger@chir.imed.uni-erlangen.de |
Study information
| Study design | Randomised controlled open multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 23/06/2003 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
91054
Germany
Sponsor information
Friedrich-Alexander University Erlangen-Nuremberg - Medical Faculty (Germany)
University/education
University/education
Prof. Dr. W. Hohenberger
Director
Department of Surgery
University Hospital Erlangen
Krankenhausstr. 12
Erlangen
91054
Germany
| Phone | +49 (0)9131 8533201 |
|---|---|
| werner.hohenberger@chir.imed.uni-erlangen.de | |
"ROR" |
https://ror.org/00f7hpc57 |
Funders
Funder type
Charity
German Cancer Aid (Deutsche Krebshilfe) (Germany) (ref: 70-3046-Ho 2)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/03/2007 | Yes | No | |
| Results article | results | 01/07/2008 | Yes | No | |
| Results article | results | 01/01/2015 | Yes | No |
