Cetuximab/FOLFIRI With or Without Oxaliplatin and FOLFOXIRI With or Without Bevacizumab in Neoadjuvant Treatment of Non-resectable Colorectal Liver Metastases

Sponsor
Technische Universität Dresden
Study ID
NCT01802645
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Cetuximab — DRUG
  • Bevacizumab — DRUG
  • Irinotecan — DRUG
  • Oxaliplatin — DRUG
  • 5-FU — DRUG
  • Folinic Acid — DRUG

Study Details

The aim of this study is to investigate the following schedules for efficacy with regard to response rate in neoadjuvant treatment of patients with non-resectable liver metastases: * Cetuximab/FOLFOXIRI and cetuximab/FOLFIRI in patients with ras wild type tumours and * Bevacizumab/FOLFOXIRI and FOLFOXIRI in patients with ras mutant tumours.

Key Dates

Start date
Mar 31, 2013
Status verified
Sep 2019
Primary completion
Sep 30, 2019
Completion
Dec 31, 2020

Study Design

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

Arms

  • Active Comparator: Cetuximab/FOLFIRI
    Cetuximab 250 mg/m² (1 h) weekly Irinotecan 180 mg/m² (1 h)\*, d-l Folinic acid 400 mg/m² (2 h), 5-FU 400 mg/m² (Bolus), 5-FU 2400 mg/m² (46 h) every 2 weeks \*reduced in UGT1A1 7/7 patients
  • Experimental: Cetuximab/FOLFOXIRI
    Cetuximab 250 mg/m² (1 h) weekly Irinotecan 125 mg/m² (1 h),\* Oxaliplatin 85 mg/m² (2 h), d-l Folinic acid 400 mg/m² (2 h), 5-FU 3200 mg/m² (46 h) every 2 weeks \*reduced in UGT1A1 7/7 patients
  • Active Comparator: FOLFOXIRI
    Irinotecan 165 mg/m² (1 h)\*, Oxaliplatin 85 mg/m² (2 h), d-l Folinic acid 400 mg/m² (2 h), 5-FU 3200 mg/m² (46 h) every 2 weeks \*reduced in UGT1A1 7/7 patients
  • Experimental: Bevacizumab/FOLFOXIRI
    Bevacizumab 5 mg/kg (30-90 min i.v.), Irinotecan 165 mg/m² (1 h),\* Oxaliplatin 85 mg/m² (2 h), d-l Folinic acid 400 mg/m² (2 h), 5-FU 3200 mg/m² (46 h) every 2 weeks \*reduced in UGT1A1 7/7 patients

Primary Outcome Measure

Response rate [ Time Frame: up to 1 year after randomization ]

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