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 designOpen prospective randomised study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymPalliative Pylorus-Preserving Pancreatododenectomy (Palliative PPPD)
Study objectivesSurvival 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) studiedPancreatic head carcinoma
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Gemcitabine (Gemzar®)
Primary outcome measureSurvival, measured after 3, 6 and 12 months
Secondary outcome measures1. 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 date15/09/2003
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants15 to 20 patients
Key inclusion criteriaMedical centres experienced in surgical and medical care of patients with pancreatic head carcinoma.
Key exclusion criteriaNo exclusion criteria.
Date of first enrolment15/09/2003
Date of final enrolment31/12/2009

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan