Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM

Sponsor
Sun Yat-sen University
Study ID
NCT03493048
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    Irinotecan 130 mg/m²
  • Cetuximab — DRUG
    Cetuximab, iv, 500mg/m2
  • 5-fluorouracil — DRUG
    5-FU 2400 mg/m² cont. inf.
  • Oxaliplatin — DRUG
    oxaliplatin 85 mg/m²
  • Leucovorin — DRUG
    leucovorin 200 mg/m²

Study Details

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis of RAS wildtype. The patients will be treated in two therapy groups: Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with FOLFOX + Cetuximab

Key Dates

Start date
Apr 15, 2018
Status verified
Jul 2025
Primary completion
Dec 30, 2022
Completion
Jun 30, 2026

Study Design

Enrollment
146 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cetuximab Plus FOLFOXIRI
    Cetuximab Plus FOLFOXIRI Patients will receive Cetuximab Plus FOLFOXIRI every 14 days: Cetuximab 500mg/m2 ivd over 90 minutes on Day 1; Oxaliplatin 85 mg/m2 ivd over 3 hours on Day 1; Irinotecan 130 mg/m2 ivd over 90 minutes on Day 1; Leucovorin (l-LV) 200mg/m2 ivd over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
  • Active Comparator: Cetuximab Plus FOLFOX
    Patients will receive Cetuximab Plus FOLFOX every 14 days: Cetuximab 500mg/m2 ivd over 90 minutes on Day 1; Oxaliplatin 85 mg/m2 ivd over 3 hours on Day 1; Leucovorin (l-LV) 200mg/m2 ivd over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.

Primary Outcome Measure

Overall Response Rate [ Time Frame: assessed up to 12 months ]

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