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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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.


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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

2 years follow-up

Safety Issue:

No

Principal Investigator

Salah-Eddin Al-Batran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Krankenhaus Nordwest

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

FLOT4

NCT ID:

NCT01216644

Start Date:

July 2010

Completion Date:

December 2015

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • perioperative
  • FLOT
  • ECF
  • pathological complete remission
  • locally advanced resectable adenocarcinoma of the esophagogastric juction or the stomach
  • Adenocarcinoma
  • Stomach Neoplasms

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