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NCT Number: NCT01216644

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Progression Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Krankenhaus Nordwest

Frankfurt, 60488, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • no previous surgical resection
  • no previous cytostatic chemotherapy
  • Age > 18 years (female and male)
  • ECOG ≤ 2
  • surgical resectability
  • Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
  • Leucocytes > 3.000/µl
  • Platelets > 100.000/µl
  • Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance > 50 ml/min
  • written informed consent.
  • Ejection fraction > 50% in echocardiography before start of therapy

Exclusion criteria

  • distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages
  • relapse
  • Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin. Epirubicin and Docetaxel
  • Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin or Docetaxel
  • Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
  • malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
  • severe non-surgical accompanying disease or acute infection
  • peripheral polyneuropathy > NCI Grad II
  • severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)
  • chronic inflammable gastro-intestinal disease
  • inclusion in another clinical trial
  • pregnancy or lactation

Treatment and study plan

5-fluorouracil

Drug

2600 mg/m²d1 i.v. every 2 weeks

Leucovorin

Drug

200 mg/m², d1, i.v., every 2 weeks

Oxaliplatin

Drug

85 mg/m², d1, i.v., every 2 weeks

docetaxel

Drug

50mg/m2, d1, i.v., every 2 weeks

Epirubicin

Drug

50 mg/m2, d1, i.v., every 3 weeks

Cisplatin

Drug

60 mg/m², d1, i.v., every 3 weeks

Primary outcomes

  1. median overall survival

    Time frame: 2 years follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Krankenhaus Nordwest

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2017
Study completion
2019
First posted
Oct 7, 2010
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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