Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003809

Trial Description

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Title

A Prospective Multicenter Study With 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

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Trial Acronym

FLOT3

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URL of the Trial

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Brief Summary in Lay Language

Patients with locally advanced or metastatic gastric carcinoma or carcinoma of the
esophagogastric junction without prior palliative therapy will be treated with 8 cycles of
the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrollment a
unique and detailed clinical evaluation of the dissemination of the disease will be done
which includes a differentiated regard of the metastatic status. patients will be classified
as having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic
disease. In arms A and B surgical intervention is planned if operability is reached. The
hypothesis is that by classifying patients more individually by the state of their disease,
patients in arm B will have a significantly prolonged overall survival compared to patients
in arm C.

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Brief Summary in Scientific Language

250 patients with locally advanced or metastatic gastric carcinoma or carcinoma of the
esophagogastric junction without prior palliative therapy will be treated with 8 cycles of
the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrolment a unique
and detailed clinical evaluation of the dissemination of the disease will be done which
includes a differentiated regard of the M-category in the TNM classification. A prospective
stratification will classify the patients as having either (A) locally advanced, (B) limited
metastatic, or (C) extensive metastatic disease. In addition, the pharmacogenetic risk
profile of the patients will be evaluated by a combined analysis of two genetic
polymorphisms of the metabolism of the applied substances (XPD312, GSTT1). For the
assessment of the disease, reference regions are examined by CT or MRI scans and if
applicable endoscopy prior to the start of the study, every 2 months during and after the
end of therapy until progression of the disease occurs. Evaluation of quality of life (by
standard forms like EORTC-Q30 and others) is continued after progression. Clinical
examinations (blood count, assessment of toxicity, anamnesis) is performed every two weeks
for evaluation of toxicity and application of chemotherapy. After informed consent is given,
peripheral blood of the patient will be analysed for the pharmacogenetic risk profile.
Representative tumor material will be analysed by immunohistochemistry and quantitative PCR
for the expression of several molecular factors.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003809
  •   2012/05/04
  •   2009/02/23
  •   yes
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Secondary IDs

  •   NCT00849615  (ClinicalTrials.gov)
  •   S396 FLOT3  (Krankenhaus Nordwest)
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Health Condition or Problem studied

  •   Gastric Cancer
  •   Adenocarcinoma of the Esophagogastric Junction
  •   C16 -  Malignant neoplasm of stomach
  •   C16.0 -  Malignant neoplasm: Cardia
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Interventions/Observational Groups

  •   Drug: Docetaxel
  •   Drug: 5-Fluorouracil
  •   Drug: Oxaliplatin
  •   Drug: folinic acid
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- overall survival; time frame: every 2 weeks during study, every 3 months follow-up

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Secondary Outcome

- Pharmacogenetic risk profile; time frame: once at beginning
- Quality of Life; time frame: every 8 weeks
- Progression free survival (PFS) and response rate (Stratum B and C); time frame: every 8 weeks
- rate of R0-resections, rate of pathological remissions and perioperative morbidity and mortality in stratum A and B Perioperative Morbidität und Mortalität in dem Arm A und ggf. B; time frame: after surgical intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2009/02/27
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Metastatic or locally advanced gastric cancer or adenocarcinoma of the
esophagogastric junction

- No prior chemotherapy in metastatic state

- Adequate blood and biochemistry parameters

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Exclusion Criteria

- Hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel

- KHK, cardiomyopathy or cardiac insufficiency

- Malignancy <5 years ago

- Brain metastases

- Severe internal disease or inadequate blood and biochemistry parameters

- Pregnancy and lactation

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Addresses

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    • Krankenhaus Nordwest
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    • Krankenhaus Nordwest
    • Salah Al-Batan, MD 
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    • Krankenhaus Nordwest
    • Salah Al-Batan, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

  •   Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, Rethwisch V, Seipelt G, Homann N, Wilhelm G, Schuch G, Stoehlmacher J, Derigs HG, Hegewisch-Becker S, Grossmann J, Pauligk C, Atmaca A, Bokemeyer C, Knuth A, Jäger E; Arbeitsgemeinschaft Internistische Onkologie. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008 Mar 20;26(9):1435-42.; 18349393
  •   Al-Batran SE, Hartmann JT, Hofheinz R, Homann N, Rethwisch V, Probst S, Stoehlmacher J, Clemens MR, Mahlberg R, Fritz M, Seipelt G, Sievert M, Pauligk C, Atmaca A, Jäger E. Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol. 2008 Jul 31; [Epub ahead of print]; 18669868
  •   Al-Batran SE, Atmaca A, Hegewisch-Becker S, Jaeger D, Hahnfeld S, Rummel MJ, Seipelt G, Rost A, Orth J, Knuth A, Jaeger E. Phase II trial of biweekly infusional fluorouracil, folinic acid, and oxaliplatin in patients with advanced gastric cancer. J Clin Oncol. 2004 Feb 15;22(4):658-63.; 14966088
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.