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Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
ISRCTN ISRCTN34802808
DOI 10.1186/ISRCTN34802808
ClinicalTrials.gov identifier
EudraCT number
Public title Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
Scientific title
Acronym CONKO-001
Serial number at source German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 200
Study hypothesis To 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.
Lay summary Not provided at time of registration
Ethics approval Ethical approval granted from the local ethical committee (Charite - Universitätsmedizin Berlin Ethik-Kommission) on the 28/11/1997 (ref: 143/97).
Study design Open, multicentre, randomised, controlled phase III trial
Countries of recruitment Austria, Germany
Disease/condition/study domain Pancreatic cancer
Participants - inclusion criteria 1. 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
Participants - exclusion criteria 1. 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
Anticipated start date 01/07/1998
Anticipated end date 31/12/2004
Status of trial Completed
Patient information material
Target number of participants 368
Interventions Patients 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).
Primary outcome measure(s) Disease-free survival (DFS)
Secondary outcome measure(s) 1. Overall survival (OS)
2. Toxicity
3. Quality of life
Sources of funding Lilly Deutschland GmbH (Germany)
Trial website
Publications 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17227978
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24104372
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24562449
Contact name Dr  Helmut  Oettle
  Address Augustenburger Platz 1
  City/town Berlin
  Zip/Postcode 13344
  Country Germany
  Email helmut.oettle@charite.de
Sponsor Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
  Address Augustenburger Platz 1
  City/town Berlin
  Zip/Postcode 13344
  Country Germany
  Email lars.roll@charite.de
  Sponsor website: http://www.charite.de/de/
Date applied 12/12/2006
Last edited 27/03/2014
Date ISRCTN assigned 21/12/2006
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