Trial document




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  DRKS00011486

Trial Description

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Title

Validity of the 5-fluorouracil plasma concentration in patients having a chemotherapy regime with 5 -fluorouracil

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Trial Acronym

CHEVAL

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The dosage of 5-Fluorouracil (5-FU) normally is based on the patient´s body surface. Nevertheless, clinical studies have shown that individual dose adjustment by therapeutic drug monitoring raised the survival time and decreased the toxicity, independent of the respective therapy regime (1, 2). For different therapy regimes the 5-FU exposition of 20 – 30 mg*h / L AUC has been proven as therapeutic range in several clinical studies regardless of tumour type and therapy regime. Using the measured 5 FU Plasma concentration the AUC value can be calculated and be checked whether the dosage corresponds to the optimal exposure. For the dosage adjustment an algorithm was developed and clinically validated (3). l The clinical aim of the individual dosage by therapeutic drug monitoring is to raise the effectiveness of the chemotherapy by concurrent reduction of the toxicity and side effects (4).
A homogeneous nanoparticle based immunoassay can be adapted in the clinical-chemical lab on autoanalyzer. The method was validated for Determination of 5-FU plasma concentration and can be used for individual dosage in the oncological practise (5).
The study contribute to the implementation of the therapeutic drug monitoring in the oncological practise, so that the patients can profit from this easy and reasonable improvement of the therapy.
Scientific aims are the characterisation of the 5-Fu chemotherapy by the monitoring of the 5 FU plasma concentration under the conditions of the practise routine with patients with a 5 FU-therapy regime and the evaluation of the relationship between the 5-FU exposition and therapy responses, toxiczity and therapy effectiveness.

References:
1. Runfeng Yang et al. Individual 5-fluorouracil dose adjustment via pharmacokinetic monitoring versus conventional body-area-surface method: A Meta-Analysis. Ther Drug Monit 2016;38:76-86
2. Paci A et al. Review of therapeutic drug monitoring of anticancer drugs part 1 – Cytotoxics. Eur J Cancer 2014;50:2010-2019
3. Kaldate RR, Haregewoin A, Grier CE, Hamilton A, McLeo HL. Modeling the 5-fluorouracil area under the curve dose relationship to develop a pharmacokinetic dosing algorithm for colorectal cancer patients receiving FOLFOX6. The Oncologist 2012;17:296-302
4. Saif M, Choma A, Salamone S, Chu E (2009): Pharmacokinetically guided dose adjustment of 5-fluorouracil: a rational approach to improving therapeutic outcomes. J Natl Cancer Inst. 2009;101:1543–1552
5. Büchel B, Sistonen J, Joerger M, et al. Comparative evaluation of the My5-FU immunoassay and the LC-MS/MS in monitoring the 5-fluorouracil plasma levels in cancer patients. Clin Chem Lab Med 2013;51:1681-88


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Organizational Data

  •   DRKS00011486
  •   2016/12/21
  •   [---]*
  •   yes
  •   Approved
  •   2016-559N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C26.0 -  Malignant neoplasm: Intestinal tract, part unspecified
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Interventions/Observational Groups

  •   The study group are patients receiving a 5- fluorouracil therapy regime
    During a therapy cycle a venous blood sample is obtained between 18 and 22 hours after start of the infusion for the determination of the 5-FU plasma concentration
    Additional clinical parameters obtained during the treatment period are used for the evaluation. These clinical parameters include demographic, anamnestic and diagnostic data as well as laboratory values and data in relation to side effects.
    The blood sample are processed in the study laboratory. The samples are centrifuged, divided in aliquots and frozen (-80°C) until measurement.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Aim is to estmate the 5-fluorouracil exposition in comparison to the 5-fluorouracil dosage

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Secondary Outcome

Relationship between 5-fluorouracil exposition and toxicity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/06/01
  •   800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

1. Age > 18 years
2. Signed informed consent
3. Having chemotherapy with 5-FU

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Exclusion Criteria

1. Age < 18 years
2. No informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Galen DiaConsult GmbH
    • Mr.  Dr.  Martin  Brusdeilins 
    • Im Talacker 15
    • 76835  Burrweiler
    • Germany
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    • TagesTherapieZentrum am Interdisziplinären Tumorzentrum Mannheim Universitätsmedizin Mannheim
    • Mr.  Prof. Dr.  Ralf-Dieter  Hofheinz 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • TagesTherapieZentrum am Interdisziplinären Tumorzentrum MannheimUniversitätsmedizin Mannheim
    • Mr.  Prof. Dr.  Ralf-Dieter  Hofheinz 
    • Theodor-Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • TagesTherapieZentrum am interdisziplinären Tumorzentrum Mannheim Universitätsmedizin Mannheim
    • Prof. Dr.  Ralf-Dieter  Hofheinz 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Galen DiaConsult GmbH
    • Dr.  Martin  Brusdeilins 
    • Im Talacker 15
    • 76835  Burrweiler
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.