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FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

NCT04393584 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2021-04-13

No results posted yet for this study

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.

Conditions

  • Stomach Neoplasms
  • Gastrointestinal Neoplasms
  • Docetaxel
  • Oxaliplatin
  • Fluoruracil
  • Irinotecan Hydrochloride

Interventions

DRUG

Irinotecan

d1 Irinotecan 180mg/m² every two weeks

DRUG

5-FU

d1-2 5-FU 2450 mg/m² every two weeks

DRUG

Leucovorin

d1 Leucovorin 200 mg/m² every two weeks

DRUG

Oxaliplatin

d1 Oxaliplatin 85 mg/m² every two weeks

DRUG

Docetaxel

d1 Docetaxel 50mg/m2 every two weeks

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Principal Investigators

  • Ivan Stilidi, PhD · NN Blokhin National Medical Research Center of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2024-01-01
Completion
2026-01-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04393584 on ClinicalTrials.gov