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

Sponsor
Blokhin's Russian Cancer Research Center
Study ID
NCT04442984
Phase
PHASE2
Status
Unknown

Conditions

  • Esophagogastric Junction Adenocarcinoma Stage IV
  • Gastric Carcinoma Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Irinotecan — DRUG
    d1 Irinotecan 180mg/m² every two weeks
  • Oxaliplatin — DRUG
    d1 Oxaliplatin 85 mg/m² every two weeks
  • 5-FU — DRUG
    d1-2 5-FU 2200 mg/m² every two weeks
  • 5-FU — DRUG
    d1 5-FU 250 mg/m² every two weeks
  • Leucovorin — DRUG
    d1 Leucovorin 400 mg every two weeks
  • 5-FU — DRUG
    d1 5-FU 400 mg/m² every two weeks
  • 5-FU — DRUG
    d1-2 5-FU 2400 mg/m² every two weeks

Study Details

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.

Key Dates

Start date
Nov 3, 2019
Status verified
Apr 2021
Primary completion
Nov 3, 2021
Completion
Nov 3, 2024

Study Design

Enrollment
326 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FOLFOX6
    5FU 400mg/m2 iv bolus d1, 5-FU 2400 mg/m² d1-2, Leucovorin 400 mg d1, Oxaliplatin 85 mg/m² d1, every two weeks (q2w) 9 cycles
  • Experimental: mFOLFIRINOX
    Irinotecan 180mg/m2 d1, 5FU 250mg/m2 iv bolus d1, 5-FU 2200 mg/m² d1-2, Leucovorin 400 mg d1, Oxaliplatin 85 mg/m² d1, every two weeks (q2w) 9 cycles

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 36 months ]

Central Contacts