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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Krankenhaus Nordwest
Sponsor:
Information provided by (Responsible Party):
PD Dr. S.E. Al-Batran, Krankenhaus Nordwest
ClinicalTrials.gov Identifier:
NCT01216644
First received: June 30, 2010
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Krankenhaus Nordwest:

Primary Outcome Measures:
  • median overall survival [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • histopathological regression rate [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
  • disease free survival (DFS) [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]
  • correlation of pCR and DFS with survival [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]
  • Perioperative Morbidity and Mortality [ Time Frame: up to 2 months after surgery ] [ Designated as safety issue: Yes ]
  • R0-Resection rate [ Time Frame: 2 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 590
Study Start Date: July 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216644

Contacts
Contact: Salah-Eddin Al-Batran, MD +496976013788 albatran@khnw.de
Contact: Claudia Pauligk, PhD +496976013906 pauligk.claudia@khnw.de

Locations
Germany
Krankenhaus Nordwest Recruiting
Frankfurt, Germany, 60488
Contact: Salah-Eddin Al-Batran, MD    +496976013788    albatran@aol.com   
Contact: Claudia Pauligk, PhD    +496976013906      
Principal Investigator: Salah-Eddin Al-Batran, MD         
Sponsors and Collaborators
Krankenhaus Nordwest
Investigators
Principal Investigator: Salah-Eddin Al-Batran, MD Krankenhaus Nordwest
  More Information

No publications provided by Krankenhaus Nordwest

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. S.E. Al-Batran, Principal Investigator, Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT01216644     History of Changes
Other Study ID Numbers: FLOT4
Study First Received: June 30, 2010
Last Updated: May 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Docetaxel
Cisplatin
Epirubicin
Fluorouracil
Leucovorin
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2014