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
Protocol serial number	German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 200
Sponsor	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Funder	Lilly Deutschland GmbH (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Helmut Oettle
Scientific

Augustenburger Platz 1
Berlin
13344
Germany

Email	helmut.oettle@charite.de

Primary study design	Interventional
Study design	Open multicentre randomised controlled phase III trial
Secondary study design	Randomised controlled trial
Scientific title	Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
Study acronym	CONKO-001
Study objectives	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(s)	Charite - Universitätsmedizin Berlin Ethik-Kommission, 28/11/1997, ref: 143/97
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Gemcitabine
Primary outcome measure(s)	Disease-free survival (DFS)
Key secondary outcome measure(s)	1. Overall survival (OS) 2. Toxicity 3. Quality of life
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	368
Key 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
Key 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
Date of first enrolment	01/07/1998
Date of final enrolment	31/12/2004

Augustenburger Platz 1

Berlin
13344
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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

02/07/2019: Publication reference added.