Condition category
Cancer
Date applied
12/12/2006
Date assigned
21/12/2006
Last edited
27/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

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 measures

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

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

http://www.charite.de/de/

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes