ClinicalTrials.gov
ClinicalTrials.gov Menu

5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01216644
Recruitment Status : Active, not recruiting
First Posted : October 7, 2010
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. S.E. Al-Batran, Krankenhaus Nordwest

Brief Summary:
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 median overall survival.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: 5-Fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Docetaxel Drug: Epirubicin Drug: Cisplatin Drug: 5-fluorouracil Phase 2 Phase 3

Detailed Description:
714 Patients with locally advanced resectable (T2-4 and/or N+, M0) 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 overall survival, secondary endpoints are disease free survival, perioperative morbidity and mortality, histopathologic regression rate and R0-resection rate.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 716 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2010
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: FLOT
Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP
Drug: 5-Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks
Drug: Leucovorin
200 mg/m², d1, i.v., every 2 weeks
Drug: Oxaliplatin
85 mg/m², d1, i.v., every 2 weeks
Drug: Docetaxel
50mg/m2, d1, i.v., every 2 weeks
Active Comparator: ECF
Epirubicin 50 mg/m2, d1 Cisplatin 60 mg/m², d1 5-FU 200 mg/m², d1-d21 every 3 weeks (q3w) 3 cycles (9 weeks) pre-OP and 3 cycles (9 weeks) post-OP
Drug: Epirubicin
50 mg/m2, d1, i.v., every 3 weeks
Drug: Cisplatin
60 mg/m², d1, i.v., every 3 weeks
Drug: 5-fluorouracil
200 mg/m², d1-d21, i.v., every 3 weeks



Primary Outcome Measures :
  1. median overall survival [ Time Frame: 2 years follow-up ]

Secondary Outcome Measures :
  1. histopathological regression rate [ Time Frame: 6 weeks after surgery ]
  2. disease free survival (DFS) [ Time Frame: 2 years follow-up ]
  3. correlation of pCR and DFS with survival [ Time Frame: 2 years follow-up ]
  4. Perioperative Morbidity and Mortality [ Time Frame: up to 2 months after surgery ]
  5. R0-Resection rate [ Time Frame: 2 months after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. locally advanced (>T1) and/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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216644


Locations
Germany
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Sponsors and Collaborators
Krankenhaus Nordwest
Investigators
Principal Investigator: Salah-Eddin Al-Batran, MD Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. S.E. Al-Batran, Principal Investigator, Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT01216644     History of Changes
Other Study ID Numbers: FLOT4
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Prof. Dr. S.E. Al-Batran, Krankenhaus Nordwest:
gastric cancer
perioperative
FLOT
ECF
pathological complete remission
locally advanced resectable adenocarcinoma of the esophagogastric juction or the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Oxaliplatin
Cisplatin
Fluorouracil
Epirubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors