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
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

Department of Surgery
Evangelisches Waldkrankenhaus Spandau
Stadtrandstrasse 555
Berlin
13589
Germany

Phone	+49 (0)30 3702 1101
Email	j.langrehr@waldkrankenhaus.com

Study information

Study design	Open prospective randomised study
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
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

Sponsor information

Humboldt University Berlin (Germany)
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
Email	jan.langrehr@charite.de
Website	http://www.charite.de/start/
"ROR"	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
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