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ISRCTN
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ISRCTN34802808
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ClinicalTrials.gov identifier
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Public title
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Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
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Scientific title
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Acronym
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CONKO-001
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Serial number at source
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German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 200
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Ethical approval granted from the local ethical committee (Charite - Universitätsmedizin Berlin Ethik-Kommission) on the 28th November 1997 (ref: 143/97).
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Study design
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Open, multicentre, randomised, controlled phase III trial
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Countries of recruitment
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Austria, Germany
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Disease/condition/study domain
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Pancreatic cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/1998
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Anticipated end date
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31/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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368
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Interventions
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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).
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Primary outcome measure(s)
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Disease free survival (DFS)
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Secondary outcome measure(s)
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1. Overall survival (OS)
2. Toxicity
3. Quality of life
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Sources of funding
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Lilly Deutschland GmbH (Germany)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/17227978
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Contact name
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Dr
Helmut
Oettle
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Address
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Augustenburger Platz 1
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City/town
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Berlin
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Zip/Postcode
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13344
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Country
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Germany
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Email
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helmut.oettle@charite.de
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Sponsor
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Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
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Address
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Augustenburger Platz 1
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City/town
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Berlin
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Zip/Postcode
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13344
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Country
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Germany
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Email
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lars.roll@charite.de
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Sponsor website:
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http://www.charite.de/de/
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Date applied
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12/12/2006
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Last edited
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10/09/2008
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Date ISRCTN assigned
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21/12/2006
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