Palliative pylorus-preserving pancreatic head resection and postoperative chemotherapy versus primary chemotherapy alone for patients with advanced carcinoma of the pancreatic head
| ISRCTN | ISRCTN20060588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20060588 |
| Protocol serial number | 2002 |
| Sponsor | Humboldt University Berlin (Germany) |
| Funder | Humboldt University Berlin (Germany) - Department of Surgery at Charité Campus Virchow Clinic |
- Submission date
- 24/05/2007
- Registration date
- 02/07/2007
- Last edited
- 21/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jan Langrehr
Scientific
Scientific
Department of Surgery
Evangelisches Waldkrankenhaus Spandau
Stadtrandstrasse 555
Berlin
13589
Germany
| Phone | +49 (0)30 3702 1101 |
|---|---|
| j.langrehr@waldkrankenhaus.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open prospective randomised study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Palliative Pylorus-Preserving Pancreatododenectomy (Palliative PPPD) |
| Study objectives | Survival and quality of life after palliative pylorus-preserving pancreatoduodenectomy and postoperative chemotherapy with Gemzar® is increased when compared to Gemzar® chemotherapy alone. |
| Ethics approval(s) | Approval received from local Institutional Review Board (IRB) (Ethics Board of the Charité, Medical Faculty, Humboldt University, now known as the Ethics Committee State Berlin) on the 30th August 2002. |
| Health condition(s) or problem(s) studied | Pancreatic head carcinoma |
| Intervention | Group 1: standard pylorus-preserving pancreatic head resection with regional lymphadenectomy (this is an internationally well accepted surgical procedure) and after completion of wound healing (up to four weeks postoperative) standard chemotherapy with gemcitabine is started (see below). The chemotherapy is the same as in group 2. Group 2: standard gemcitabine chemotherapy alone: 1000 mg/m^2 body surface once per week for four weeks with a one-week break, i.e., three weeks treatment and one week free. This is an internationally accepted standard for gemcitabine in advanced pancreatic carcinoma treatment. Drugs will be administered on an out patient basis intravenously (i.v.) through a port system. Follow up period is one year. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gemcitabine (Gemzar®) |
| Primary outcome measure(s) |
Survival, measured after 3, 6 and 12 months |
| Key secondary outcome measure(s) |
1. Quality of life, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) and the EORTC Quality of Life Questionnaire for Pancreatic cancer (QLQ PAN26). This will be measured after 3, 6 and 12 months |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | Medical centres experienced in surgical and medical care of patients with pancreatic head carcinoma. |
| Key exclusion criteria | No exclusion criteria. |
| Date of first enrolment | 15/09/2003 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Surgery
Berlin
13589
Germany
13589
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 |
