Palliative pylorus-preserving pancreatic head resection and postoperative chemotherapy versus primary chemotherapy alone for patients with advanced carcinoma of the pancreatic head
ISRCTN | ISRCTN20060588 |
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DOI | https://doi.org/10.1186/ISRCTN20060588 |
Secondary identifying numbers | 2002 |
- 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 |
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j.langrehr@waldkrankenhaus.com |
Study information
Study design | Open prospective randomised study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Gemcitabine (Gemzar®) |
Primary outcome measure | Survival, measured after 3, 6 and 12 months |
Secondary outcome measures | 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 2. Surgical complications, measured after 3, 6 and 12 months 3. Toxicity of chemotherapy, measured after 3, 6 and 12 months |
Overall study start date | 15/09/2003 |
Completion date | 31/12/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 15 to 20 patients |
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
Sponsor information
Humboldt University Berlin (Germany)
University/education
University/education
Department of General-, Viszeral- and Transplantational-Surgery
Charite Universitaetsmedizin Berlin
Campus Virchow-Klinikum
Augustenburger Platz 1
Berlin
13353
Germany
Phone | +49 (0)30 450 552001 |
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jan.langrehr@charite.de | |
Website | http://www.charite.de/start/ |
https://ror.org/01hcx6992 |
Funders
Funder type
University/education
Humboldt University Berlin (Germany) - Department of Surgery at Charité Campus Virchow Clinic
No information available
Results and Publications
Intention to publish date | |
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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 |