# FLOT4-AIO

Source: https://onco.cc/trials/flot4/  
OnCo record `flot4` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

FLOT4 showed that a docetaxel-based chemotherapy given before and after surgery helped people with operable stomach and junction cancers live longer than the older epirubicin-based regimen, and FLOT became the standard perioperative treatment in Europe.

## Summary

The German FLOT4-AIO trial randomised 716 patients with resectable adenocarcinoma of the stomach or gastro-oesophageal junction (clinical stage T2 or higher, or node-positive) to four cycles before and four after surgery of FLOT (fluorouracil, leucovorin, oxaliplatin and docetaxel) or three cycles before and after of ECF or ECX (epirubicin, cisplatin, and fluorouracil or capecitabine), the regimen established by the MAGIC trial. The phase 2 part compared pathological response; the phase 3 primary endpoint was overall survival.

FLOT increased the rate of complete or near-complete pathological regression and lengthened overall survival compared with ECF or ECX, with a similar rate of surgical complications. It replaced the anthracycline triplet as the perioperative standard in Europe and is the backbone that ESOPEC, MATTERHORN and other trials have since built on.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Also known as: FLOT4; AIO-FLOT4
- Tags: subtype-trials
- Registry id: NCT01216644
- Phase: 2/3
- Setting: Resectable gastric or gastro-oesophageal junction adenocarcinoma: perioperative FLOT (fluorouracil, leucovorin, oxaliplatin, docetaxel) against perioperative ECF or ECX
- Sponsor: Krankenhaus Nordwest (AIO)
- Enrolled: 716
- Result: Perioperative FLOT improved overall survival over ECF or ECX in resectable gastric and junctional adenocarcinoma.

## Sources

- ClinicalTrials.gov NCT01216644: https://clinicaltrials.gov/study/NCT01216644

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Oesophageal and junctional adenocarcinoma](https://onco.cc/cancers/oesophageal-adenocarcinoma/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Docetaxel](https://onco.cc/drugs/docetaxel/), [Epirubicin](https://onco.cc/drugs/epirubicin/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- people: [Salah-Eddin Al-Batran](https://onco.cc/people/salah-eddin-al-batran/)
- key papers: [FLOT4-AIO: perioperative FLOT versus ECF/ECX for resectable gastric or gastro-oesophageal junction adenocarcinoma](https://onco.cc/key-papers/paper-flot4-lancet-2019/)

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