Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003761

Trial Description

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Title

A Randomized Multicenter Phase II/III Study Comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced Resectable Adenocarcinoma of the Esophagogastreal Junction or the Stomach

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients with locally advanced resectable adenocarcinoma of the stomach or the
esophagogastreal junction without previous therapy will be treated with one of two
chemotherapy combinations before and after surgery. One half of the patients gets
5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin,
Cisplatin and 5-FU (ECF). Main objective of the study is the increase of the pathological
complete responses (pCR) with FLOT versus the ECF treatment.

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Brief Summary in Scientific Language

590 Patients with locally advanced resectable (T2-4 and/or N+, M10) adenocarcinoma of the
stomach or the esophagogastreal junction without previous therapy will be included in this
study. After randomization patients receive perioperatively 4 cycles FLOT or 3 cycles ECF,
followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of
FLOT or 3 cycles ECF are applicated. Then a central validation of the pathological remission
rate is scheduled. Primary endpoint is disease free survival, secondary endpoints are
overall survival,perioperative morbidity and mortality, histopathologic regression rate and
R0-resection rate.

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Organizational Data

  •   DRKS00003761
  •   2012/05/03
  •   2010/06/30
  •   yes
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  •   [---]*
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Secondary IDs

  •   NCT01216644  (ClinicalTrials.gov)
  •   FLOT4  (Krankenhaus Nordwest)
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Health Condition or Problem studied

  •   Gastric Cancer
  •   C16 -  Malignant neoplasm of stomach
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Interventions/Observational Groups

  •   Drug: 5-Fluorouracil
  •   Drug: Leucovorin
  •   Drug: Oxaliplatin
  •   Drug: Docetaxel
  •   Drug: Epirubicin
  •   Drug: Cisplatin
  •   Drug: 5-fluorouracil
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II-III
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Primary Outcome

- Disease free survival; time frame: 2 years follow-up

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Secondary Outcome

- histopathological regression rate; time frame: 6 weeks after surgery
- overall survival (OS); time frame: 2 years follow-up (maximum 5 years)
- correlation of pCR and DFS with survival; time frame: 2 years follow-up
- Perioperative Morbidity and Mortality; time frame: up to 2 months after surgery
- R0-Resection rate; time frame: 2 months after surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2010/07/31
  •   590
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. locally advanced (>T1) or nodal positive (N+) histologically proven adenocarcinoma of
the esophagogastreal junction (AEG I-III) or the stomach without distant metastases
(M0) and without infiltration of adjacent structures and organs

2. no previous surgical resection

3. no previous cytostatic chemotherapy

4. Age > 18 years (female and male)

5. ECOG ≤ 2

6. surgical resectability

7. Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy

8. Leucocytes > 3.000/µl

9. Platelets > 100.000/µl

10. Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance > 50 ml/min

11. written informed consent.

12. Ejection fraction > 50% in echocardiography before start of therapy

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Exclusion Criteria

1. distant metastases or infiltration of adjacent structures or organs and all primarily
not resectable stages

2. relapse

3. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin.
Epirubicin and Docetaxel

4. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin,
Cisplatin, Epirubicin or Docetaxel

5. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA

6. malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of
the cervix uteri, adequately treated skin basal cell carcinoma)

7. severe non-surgical accompanying disease or acute infection

8. peripheral polyneuropathy > NCI Grad II

9. severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)

10. chronic inflammable gastro-intestinal disease

11. inclusion in another clinical trial

12. pregnancy or lactation

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Addresses

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    • Krankenhaus Nordwest
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    • Krankenhaus Nordwest
    • Salah-Eddin Al-Batran, MD 
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    •   [---]*
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    • Salah-Eddin Al-Batran, 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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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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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 .
  •   91
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.