Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
ISRCTN | ISRCTN34802808 |
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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
Scientific
Augustenburger Platz 1
Berlin
13344
Germany
helmut.oettle@charite.de |
Study information
Study design | Open multicentre randomised controlled phase III trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Gemcitabine |
Primary outcome measure | Disease-free survival (DFS) |
Secondary outcome measures | 1. Overall survival (OS) 2. Toxicity 3. Quality of life |
Overall study start date | 01/07/1998 |
Completion date | 31/12/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Austria
- Germany
Study participating centre
Augustenburger Platz 1
Berlin
13344
Germany
13344
Germany
Sponsor information
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Augustenburger Platz 1
Berlin
13344
Germany
lars.roll@charite.de | |
Website | http://www.charite.de/de/ |
https://ror.org/001w7jn25 |
Funders
Funder type
Industry
Lilly Deutschland GmbH (Germany)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.