Condition category
Cancer
Date applied
24/05/2007
Date assigned
02/07/2007
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.charite.de/start/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes