Condition category
Cancer
Date applied
24/07/2007
Date assigned
21/12/2007
Last edited
21/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.conko-studien.de/

Contact information

Type

Scientific

Primary contact

Dr Helmut Oettle

ORCID ID

Contact details

Augustenburger Platz 1
Berlin
13344
Germany
+49 (0)30 450 553 222
helmut.oettle@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 427; CONKO-003

Study information

Scientific title

Acronym

Study hypothesis

Study hypothesis:
To test the hypothesis that second-line chemotherapy with OFF improves overall survival compared to best supportive care alone.

Amendment 1:
To test the hypothesis that second-line chemotherapy with OFF improves overall survival compared to folinic acid/5-fluorouracil (24-hour) and best supportive care alone (FF).

Ethics approval

Approval received from the Ethikkommission der Charite Universitatsmedizin Berlin on the 14th October 2002 (ref: 192/2002); amendment 1 approved on 12th December 2003.

Study design

Prospective, 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

After stratification for duration of first line therapy, Karnofsky Performance Status (KPS) and tumour stage, patients were randomised and treated with 5-fluorouracil (FU) 2 g/m^2 (24-hour)/folinic acid (FA) 200 mg/m^2 (FF) on days 1, 8, 15 and 22 with or without oxaliplatin 85 mg/m^2 (2-hour) on days 8 and 22. Therapy paused on days 23 to 42.

Intervention type

Drug

Phase

Phase III

Drug names

Oxaliplatin, folinic acid, 5-fluorouracil

Primary outcome measures

Overall survival, progression free survival: Kaplan Meyer Plot (current version of SPSS).

Secondary outcome measures

1. Rate of remission: description with tabulations, as percentage of the two treatment groups, duration of remission
2. Toxicity: NCI Common Toxicity Criteria (CTC) grade differentation, description with tabulations
3. Quality of life: tabulation descriptions, assesment with box-plot (current version of SPSS)

Overall trial start date

01/01/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically proven advanced pancreatic cancer after confirmed failure of treatment with gemcitabine
2. No more than three weeks between confirmed failure of treatment with gemcitabine and start of second-line therapy
3. Karnofsky performance status greater than 70%
4. Measurable disease of more than 15 x 15 mm per computed tomography (CT) or magnetic resonance (MR) scan
5. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L
6. Written informed consent
7. Age of 18 years or more
8. Sufficient contraception up to three months after the end of therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

165

Participant exclusion criteria

1. Active infection (as decided by physician)
2. Pregnant or breastfeeding women
3. Psychiatric disorders
4. Heavy disorders, contradictory with study (as decided by physician)
5. Heavy complications of the tumour, requiring an acute therapy
6. Heavy cardiac disorders
7. Peripheral, sensory and/or motor neuropathy (greater than II° - grade of sensoric/motoric toxicity regarding National Cancer Institute [NCI] criteria)
8. Hyperesthesia against study medication or related drugs
9. Patients with renal failure (creatinine clearance less than 30 ml/min)

Recruitment start date

01/01/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Augustenburger Platz 1
Berlin
13344
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

Augustenburger Platz 1
Berlin
13344
Germany
+49 (0)30 450 553 222
lars.roll@charite.de

Sponsor type

University/education

Website

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

Funders

Funder type

Industry

Funder name

Amgen GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medac (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ribosepharm GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sanofi-Aventis 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

Publication citations

Additional files

Editorial Notes