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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04393584
Study type Interventional
Source Blokhin's Russian Cancer Research Center
Contact Aleksei Kalinin, Phd
Phone +79197681276
Email kalininalexey1986@yandex.ru
Status Recruiting
Phase Phase 2/Phase 3
Start date January 29, 2019
Completion date January 1, 2026

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