FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

  • End date
    Jan 1, 2026
  • participants needed
  • sponsor
    Blokhin's Russian Cancer Research Center
Updated on 22 April 2021
absolute neutrophil count
combination chemotherapy
gastric adenocarcinoma
neutrophil count
cancer chemotherapy


Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction (II-III type by Siewert) 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 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.


538 Patients with resectable (cT4cN0 or cT1-4 and cN+, cM0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or FOLFIRINOX, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or FOLFIRNOX are applicated.

Condition Fluorouracil, Gastrointestinal Neoplasm, GASTROINTESTINAL DISORDER, Gastrointestinal Diseases and Disorders, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Gastrointestinal Diseases and Disorders, Docetaxel, Stomach Cancer, Digestive System Neoplasms, Oxaliplatin, Irinotecan Hydrochloride, gastric neoplasm, gastric tumor, 5-fluorouracil, 5-fu, gastrointestinal tumor, gastrointestinal tract tumor, gastrointestinal tumors, digestive system tumor
Treatment docetaxel, Irinotecan, Oxaliplatin, 5-FU, Leucovorin
Clinical Study IdentifierNCT04393584
SponsorBlokhin's Russian Cancer Research Center
Last Modified on22 April 2021


Yes No Not Sure

Inclusion Criteria

T4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)
No previous cytostatic chemotherapy or radiation therapy
Age 18-70 years (female and male)
Eastern Cooperative Oncology Group 2
Surgical resectability
Neutrophils> 2.000/l
Platelets > 100.000/l
Normal value of Serum Creatinin
Albumin level > 29
Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN)
Total Bilirubin less than 1.5 times the ULN
Written informed consent

Exclusion Criteria

Previous cytostatic chemotherapy or radiation therapy
Distant metastases or all primarily not resectable stages
Cancer relapse
Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV)
Diarrhea 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1
Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and Docetaxel
Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel
Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA)
Severe non-surgical accompanying disease or acute infection (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors and others)
Malignant secondary disease, dated back < 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)
Peripheral polyneuropathy > Grad II
Liver dysfunction (AST)/ALT>3,0xULN, ALT>3xULN, Bilirubin>1,5xULN)
Serum Creatinin >1,0xULN
Chronic inflammable gastro-intestinal disease
Inclusion in another clinical trial
Pregnancy or lactation
Hepatitis B or C in the active stage
Human immunodeficiency virus(HIV) infected
Serious concomitant somatic and mental illnesses / deviations or territorial causes that may prevent the patient from participating in the protocol and observing the protocol schedule
Foreigners or persons with limited legal status
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note