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FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)

NCT04442984 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2021-04-13

No results posted yet for this study

Summary

Patients with metastatic 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 . One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin (FOLFOX6), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (mFOLFIRINOX). Main objective of the study is progression free survival.

Conditions

  • Gastric Carcinoma Stage IV
  • Esophagogastric Junction Adenocarcinoma Stage IV

Interventions

DRUG

Irinotecan

d1 Irinotecan 180mg/m² every two weeks

DRUG

Oxaliplatin

d1 Oxaliplatin 85 mg/m² every two weeks

DRUG

5-FU

d1-2 5-FU 2200 mg/m² every two weeks

DRUG

5-FU

d1 5-FU 250 mg/m² every two weeks

DRUG

Leucovorin

d1 Leucovorin 400 mg every two weeks

DRUG

5-FU

d1 5-FU 400 mg/m² every two weeks

DRUG

5-FU

d1-2 5-FU 2400 mg/m² every two weeks

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-03
Primary Completion
2021-11-03
Completion
2024-11-03

Countries

  • Russia

Study Locations

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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 NCT04442984 on ClinicalTrials.gov