TWICE-IRI: Optimization of Second-line Therapy With Aflibercept, Irinotecan (Day 1 or Day 1,3), 5-Fluorouracile and Folinic Acid in Patients With Metastatic Colorectal Cancer. A Randomized Phase III Study.

Sponsor
Hôpital Franco-Britannique-Fondation Cognacq-Jay
Study ID
NCT04392479
Phase
PHASE3
Status
Unknown

Conditions

  • Cancer Colorectal
  • Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Optimization of second-line therapy with aflibercept, irinotecan (day1 or day 1,3), 5fluorouracile and folinic acid in patients with metastatic colorectal cancer. A randomized Phase III study.

Key Dates

Start date
Sep 2, 2020
Status verified
Oct 2023
Primary completion
Jun 15, 2023
Completion
Jun 30, 2024

Study Design

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

Arms

  • Active Comparator: Aflibercept-FOLFIRI (arm 1)
    * Aflibercept (D1) H0: 4mg/kg IV infusion over 60min (+ 2-minute window), * Folinic acid (D1) H+1: 400mg/m² IV infusion over 120min (+ 2-minute window), * Irinotecan (D1) H+1: 180mg/m² IV infusion over 60min (+ 2-minute window), * 5-fluorouracile (D1) H+3: 400mg/m² IV infusion over 15min (+ 2-minute window), * 5-fluorouracile (D1 to D3): H+3.5: 2400mg/m² IV infusion over 46 hours (+ 1hour window) * H+49.5: End of treatment administration
  • Experimental: Aflibercept-mFOLFIRI3 (arm 2)
    * Aflibercept (D1) H0: 4mg/kg IV infusion over 60min (+ 2-minute window), * Folinic acid (D1) H+1: 400mg/m² IV infusion over 120min (+ 2-minute window), * Irinotecan (D1 and D3) H+1 and H+49: 75mg/m² IV infusion over 60min (+ 2-minute window) on cycles 1 and 2, then 90mg/m² at cycle 3 and furthers in absence of AEs grade ≥2, * 5-fluorouracile (D1 to D3) H+3: 2400mg/m² IV infusion over 46 hours (+ 1hour window) * H+50: End of treatment administration

Primary Outcome Measure

Overall response rate (ORR). [ Time Frame: 2 months ]

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