Contact information
Type
Scientific
Primary contact
Prof Jan Langrehr
ORCID ID
Contact details
Department of Surgery
Evangelisches Waldkrankenhaus Spandau
Stadtrandstrasse 555
Berlin
13589
Germany
+49 (0)30 3702 1101
j.langrehr@waldkrankenhaus.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2002
Study information
Scientific title
Acronym
Palliative Pylorus-Preserving Pancreatododenectomy (Palliative PPPD)
Study hypothesis
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
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.
Study design
Open prospective randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
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 trial start date
15/09/2003
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Medical centres experienced in surgical and medical care of patients with pancreatic head carcinoma.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
15 to 20 patients
Participant exclusion criteria
No exclusion criteria.
Recruitment start date
15/09/2003
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Surgery
Berlin
13589
Germany
Sponsor information
Organisation
Humboldt University Berlin (Germany)
Sponsor details
Department of General-
Viszeral- and Transplantational-Surgery
Charite Universitaetsmedizin Berlin
Campus Virchow-Klinikum
Augustenburger Platz 1
Berlin
13353
Germany
+49 (0)30 450 552001
jan.langrehr@charite.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Humboldt University Berlin (Germany) - Department of Surgery at Charité Campus Virchow Clinic
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
Basic results (scientific)
Publication list