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NCT01216644 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2, PHASE3
Status at capture
COMPLETED
Registry last update
2019-06-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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
    intervention Names
    1. Drug: 5-Fluorouracil
    2. Drug: Leucovorin
    3. Drug: Oxaliplatin
    4. Drug: Docetaxel
    label
    FLOT
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Drug: Epirubicin
    2. Drug: Cisplatin
    3. Drug: 5-fluorouracil
    label
    ECF
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. FLOT
    description
    2600 mg/m²d1 i.v. every 2 weeks
    name
    5-Fluorouracil
    type
    DRUG
  2. arm Group Labels
    1. FLOT
    description
    200 mg/m², d1, i.v., every 2 weeks
    name
    Leucovorin
    type
    DRUG
  3. arm Group Labels
    1. FLOT
    description
    85 mg/m², d1, i.v., every 2 weeks
    name
    Oxaliplatin
    type
    DRUG
  4. arm Group Labels
    1. FLOT
    description
    50mg/m2, d1, i.v., every 2 weeks
    name
    Docetaxel
    type
    DRUG
  5. arm Group Labels
    1. ECF
    description
    50 mg/m2, d1, i.v., every 3 weeks
    name
    Epirubicin
    type
    DRUG
  6. arm Group Labels
    1. ECF
    description
    60 mg/m², d1, i.v., every 3 weeks
    name
    Cisplatin
    type
    DRUG
  7. arm Group Labels
    1. ECF
    description
    200 mg/m², d1-d21, i.v., every 3 weeks
    name
    5-fluorouracil
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
716
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    median overall survival
    time Frame
    2 years follow-up
secondary Outcomes
  1. measure
    histopathological regression rate
    time Frame
    6 weeks after surgery
  2. measure
    disease free survival (DFS)
    time Frame
    2 years follow-up
  3. measure
    correlation of pCR and DFS with survival
    time Frame
    2 years follow-up
  4. measure
    Perioperative Morbidity and Mortality
    time Frame
    up to 2 months after surgery
  5. measure
    R0-Resection rate
    time Frame
    2 months after surgery
Full study description
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.
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.
Source references
references
  1. citation
    Zeng H, Wang C, Song LY, Jia SJ, Zeng X, Liu Q. Economic evaluation of FLOT and ECF/ECX perioperative chemotherapy in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma. BMJ Open. 2022 Nov 14;12(11):e060983. doi: 10.1136/bmjopen-2022-060983.
    pmid
    36375981
    type
    DERIVED
  2. citation
    Koch C, Reitz C, Schreckenbach T, Eichler K, Filmann N, Al-Batran SE, Gotze T, Zeuzem S, Bechstein WO, Kraus T, Bojunga J, Dux M, Trojan J, Blumenstein I. Sarcopenia as a prognostic factor for survival in patients with locally advanced gastroesophageal adenocarcinoma. PLoS One. 2019 Oct 22;14(10):e0223613. doi: 10.1371/journal.pone.0223613. eCollection 2019.
    pmid
    31639132
    type
    DERIVED
  3. citation
    Al-Batran SE, Homann N, Pauligk C, Goetze TO, Meiler J, Kasper S, Kopp HG, Mayer F, Haag GM, Luley K, Lindig U, Schmiegel W, Pohl M, Stoehlmacher J, Folprecht G, Probst S, Prasnikar N, Fischbach W, Mahlberg R, Trojan J, Koenigsmann M, Martens UM, Thuss-Patience P, Egger M, Block A, Heinemann V, Illerhaus G, Moehler M, Schenk M, Kullmann F, Behringer DM, Heike M, Pink D, Teschendorf C, Lohr C, Bernhard H, Schuch G, Rethwisch V, von Weikersthal LF, Hartmann JT, Kneba M, Daum S, Schulmann K, Weniger J, Belle S, Gaiser T, Oduncu FS, Guntner M, Hozaeel W, Reichart A, Jager E, Kraus T, Monig S, Bechstein WO, Schuler M, Schmalenberg H, Hofheinz RD; FLOT4-AIO Investigators. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial. Lancet. 2019 May 11;393(10184):1948-1957. doi: 10.1016/S0140-6736(18)32557-1. Epub 2019 Apr 11.
    pmid
    30982686
    type
    DERIVED
  4. citation
    Al-Batran SE, Hofheinz RD, Pauligk C, Kopp HG, Haag GM, Luley KB, Meiler J, Homann N, Lorenzen S, Schmalenberg H, Probst S, Koenigsmann M, Egger M, Prasnikar N, Caca K, Trojan J, Martens UM, Block A, Fischbach W, Mahlberg R, Clemens M, Illerhaus G, Zirlik K, Behringer DM, Schmiegel W, Pohl M, Heike M, Ronellenfitsch U, Schuler M, Bechstein WO, Konigsrainer A, Gaiser T, Schirmacher P, Hozaeel W, Reichart A, Goetze TO, Sievert M, Jager E, Monig S, Tannapfel A. Histopathological regression after neoadjuvant docetaxel, oxaliplatin, fluorouracil, and leucovorin versus epirubicin, cisplatin, and fluorouracil or capecitabine in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4-AIO): results from the phase 2 part of a multicentre, open-label, randomised phase 2/3 trial. Lancet Oncol. 2016 Dec;17(12):1697-1708. doi: 10.1016/S1470-2045(16)30531-9. Epub 2016 Oct 22.
    pmid
    27776843
    type
    DERIVED
  5. citation
    Lorenzen S, Thuss-Patience P, Al-Batran SE, Lordick F, Haller B, Schuster T, Pauligk C, Luley K, Bichev D, Schumacher G, Homann N. Impact of pathologic complete response on disease-free survival in patients with esophagogastric adenocarcinoma receiving preoperative docetaxel-based chemotherapy. Ann Oncol. 2013 Aug;24(8):2068-73. doi: 10.1093/annonc/mdt141. Epub 2013 Apr 16.
    pmid
    23592699
    type
    DERIVED
Source notices and limitations
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        );">Level of evidence A1</a>]</p><p id="_635" tabindex="-1">In addition, in the randomized phase III <a href="/clinicaltrials/NCT01216644">AIO-FLOT4</a> trial (NCT01216644), patients with resectable disease that was stage T2 or higher and/or node positive received either perioperative epirubicin, cisplatin, and 5-FU or capecitabi
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        emotherapy):</p> <div class="pdq-content-list"><ol id="_639"><li>In the randomized phase III <a href="/clinicaltrials/NCT01216644">AIO-FLOT4</a> trial (NCT01216644), 716 patients with stage IB to stage III resectable gastric or gastroesophageal adenocarcinoma were randomly assigned to receive either perioperative chemothe
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      source update dates
      1. context
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        datetime
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    Preserved source evidence · Not medical advice