Clinical Trials Directory

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UnknownNCT04393584

FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

Perioperative Chemotherapy With FOLFIRINOX Regimen or FLOT Regimen for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial

Status
Unknown
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
538 (estimated)
Sponsor
Blokhin's Russian Cancer Research Center · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGIrinotecand1 Irinotecan 180mg/m² every two weeks
DRUG5-FUd1-2 5-FU 2450 mg/m² every two weeks
DRUGLeucovorind1 Leucovorin 200 mg/m² every two weeks
DRUGOxaliplatind1 Oxaliplatin 85 mg/m² every two weeks
DRUGDocetaxeld1 Docetaxel 50mg/m2 every two weeks

Timeline

Start date
2019-01-29
Primary completion
2024-01-01
Completion
2026-01-01
First posted
2020-05-19
Last updated
2021-04-13

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT04393584. Inclusion in this directory is not an endorsement.