Contact information
Type
Scientific
Primary contact
Dr Helmut Oettle
ORCID ID
Contact details
Augustenburger Platz 1
Berlin
13344
Germany
-
helmut.oettle@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 200
Study information
Scientific title
Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
Acronym
CONKO-001
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.
Ethics approval
Charite - Universitätsmedizin Berlin Ethik-Kommission, 28/11/1997, ref: 143/97
Study design
Open multicentre randomised controlled phase III trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pancreatic cancer
Intervention
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).
Intervention type
Drug
Phase
Phase III
Drug names
Gemcitabine
Primary outcome measure
Disease-free survival (DFS)
Secondary outcome measures
1. Overall survival (OS)
2. Toxicity
3. Quality of life
Overall trial start date
01/07/1998
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
368
Participant 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
Recruitment start date
01/07/1998
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Austria, Germany
Trial participating centre
Augustenburger Platz 1
Berlin
13344
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Sponsor details
Augustenburger Platz 1
Berlin
13344
Germany
-
lars.roll@charite.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Lilly Deutschland GmbH (Germany)
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
Basic results (scientific)
Publication list
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25314063
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26049689
Publication citations
-
Results
Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H, Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial., JAMA, 2007, 297, 3, 267-277, doi: 10.1001/jama.297.3.267.
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Results
Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zülke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H, Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial., JAMA, 2013, 310, 14, 1473-1481, doi: 10.1001/jama.2013.279201.
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Results
Sinn M, Sinn BV, Striefler JK, Lindner JL, Stieler JM, Lohneis P, Bischoff S, Bläker H, Pelzer U, Bahra M, Dietel M, Dörken B, Oettle H, Riess H, Denkert C, SPARC expression in resected pancreatic cancer patients treated with gemcitabine: results from the CONKO-001 study., Ann. Oncol., 2014, 25, 5, 1025-1032, doi: 10.1093/annonc/mdu084.
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Results
Sinn M, Denkert C, Striefler JK, Pelzer U, Stieler JM, Bahra M, Lohneis P, Dörken B, Oettle H, Riess H, Sinn BV, α-Smooth muscle actin expression and desmoplastic stromal reaction in pancreatic cancer: results from the CONKO-001 study, Br J Cancer, 2014 , 111, 10, 1917-1923, doi: 10.1038/bjc.2014.495.
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Results
Sinn M, Riess H, Sinn BV, Stieler JM, Pelzer U, Striefler JK, Oettle H, Bahra M, Denkert C, Bläker H, Lohneis P, Human equilibrative nucleoside transporter 1 expression analysed by the clone SP 120 rabbit antibody is not predictive in patients with pancreatic cancer treated with adjuvant gemcitabine - Results from the CONKO-001 trial, Eur J Cancer, 2015 , 51, 12, 1546-1554, doi: 10.1016/j.ejca.2015.05.005.