Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial

ISRCTN ISRCTN34802808
DOI https://doi.org/10.1186/ISRCTN34802808
Secondary identifying numbers German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 200
Submission date
12/12/2006
Registration date
21/12/2006
Last edited
02/07/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helmut Oettle
Scientific

Augustenburger Platz 1
Berlin
13344
Germany

Email helmut.oettle@charite.de

Study information

Study designOpen multicentre randomised controlled phase III trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAdjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
Study acronymCONKO-001
Study objectivesTo test the hypothesis that adjuvant chemotherapy with gemcitabine administered after complete resection of pancreatic cancer improves disease-free survival (DFS) by six months or more.
Ethics approval(s)Charite - Universitätsmedizin Berlin Ethik-Kommission, 28/11/1997, ref: 143/97
Health condition(s) or problem(s) studiedPancreatic cancer
InterventionPatients were randomised, with stratification for resection, T and nodal status, to receive adjuvant chemotherapy with six cycles of gemcitabine day one, eight and 15 every four weeks (Arm A) or observation (Arm B).
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Gemcitabine
Primary outcome measureDisease-free survival (DFS)
Secondary outcome measures1. Overall survival (OS)
2. Toxicity
3. Quality of life
Overall study start date01/07/1998
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants368
Key inclusion criteria1. Histologically proven resected pancreatic carcinoma
2. Standard operation
3. No measurable disease
4. No prior chemo- or radiotherapy
5. No active infection
6. Karnofsky performance status minimum 50%
7. Adequate haematologic, renal and hepatic function
8. Cancer antigen 19-9 (CA 19-9), carcinoembryonic antigen (CEA) less than 2.5 x upper limit of normal (ULN)
9. Start with adjuvant therapy within six weeks after resection
10. Written informed consent
Key exclusion criteria1. Active infection
2. Impaired coagulation (international normalised ratio [INR] and/or activated partial thromboplastin time [aPPT] more than 1.5 x ULN)
3. Transaminases more than 3 x ULN
4. Serum creatinine more than 1.5 x ULN
5. Postoperative tumour markers (CEA/CA19-9) more than 2.5 x ULN
6. History of another malignant disease other than carcinoma in situ of the uterine cervix or adequately treated basal cell carcinoma of the skin
7. Pregnant or breastfeeding women
Date of first enrolment01/07/1998
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Austria
  • Germany

Study participating centre

Augustenburger Platz 1
Berlin
13344
Germany

Sponsor information

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Hospital/treatment centre

Augustenburger Platz 1
Berlin
13344
Germany

Email lars.roll@charite.de
Website http://www.charite.de/de/
ROR logo "ROR" https://ror.org/001w7jn25

Funders

Funder type

Industry

Lilly Deutschland GmbH (Germany)

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 17/01/2007 Yes No
Results article results 09/10/2013 Yes No
Results article results 01/05/2014 Yes No
Results article results 11/11/2014 Yes No
Results article results 01/08/2015 Yes No
Results article results 01/05/2018 02/07/2019 Yes No

Editorial Notes

02/07/2019: Publication reference added.