Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr Helmut Oettle

ORCID ID

Contact details

Augustenburger Platz 1
Berlin
13344
Germany
-
helmut.oettle@charite.de

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 200

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(s)

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

Study setting(s)

Hospital

Study 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

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

Overall study end date

31/12/2004

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Not Specified

Sex

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

Countries of recruitment

Austria, Germany

Study participating centre

Augustenburger Platz 1
Berlin
13344
Germany

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/

ROR

https://ror.org/001w7jn25

Funder type

Industry

Funder name

Lilly Deutschland GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs