FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

Sponsor
Blokhin's Russian Cancer Research Center
Study ID
NCT04393584
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    d1 Irinotecan 180mg/m² every two weeks
  • 5-FU — DRUG
    d1-2 5-FU 2450 mg/m² every two weeks
  • Leucovorin — DRUG
    d1 Leucovorin 200 mg/m² every two weeks
  • Oxaliplatin — DRUG
    d1 Oxaliplatin 85 mg/m² every two weeks
  • Docetaxel — DRUG
    d1 Docetaxel 50mg/m2 every two weeks

Study Details

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.

Key Dates

Start date
Jan 29, 2019
Status verified
Apr 2021
Primary completion
Jan 1, 2024
Completion
Jan 1, 2026

Study Design

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

Arms

  • Experimental: FOLFIRINOX
    Irinotecan 180mg/m2 d1, d1-2 5-FU 2450 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (4-8 weeks) pre-OP and 4 cycles (6-12 weeks) post-OP
  • Active Comparator: FLOT
    d1 Docetaxel 50mg/m2, d1-2 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m² every two weeks (q2w) 4 cycles (4-8 weeks) pre-OP and 4 cycles (6-12 weeks) post-OP

Primary Outcome Measure

median overall survival [ Time Frame: 2 years ]

Central Contacts

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