Improving SUrgery of Liver Metastases: a Trial of the Arterial Chemotherapy Network

Sponsor
UNICANCER
Study ID
NCT03164655
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Oxaliplatin, Cetuximab, Bevacizumab, Panitumumab, Irinotecan, Leucovorin, 5-Fluorouracil — DRUG
    Oxaliplatin 100 mg/m² infusion in 2 hours, Cetuximab 500mg/m² infusion in 2 hours, Bevacizumab 5 mg/kg infusion in 30 minutes, Panitumumab 6 mg/kg, Irinotecan 180 mg/m² over 90 minutes to begin 30 minutes after folinic acid infusion is started, Leucovorin 400 mg/m² infusion in 2 hours, 5-Fluorouracil 2400 mg/m² infusion continuous in 46h

Study Details

National trial, multicenter, randomized, phase II comparing treatment intensification with hepatic arterial infusion chemotherapy plus systemic chemotherapy (CT) to systemic chemotherapy alone in patients with liver-only colorectal metastases (CRLM) considered still non resectable after at least two months of systemic induction chemotherapy.

Key Dates

Start date
Jul 25, 2018
Status verified
Sep 2024
Primary completion
Jul 15, 2021
Completion
Nov 15, 2021

Study Design

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

Arms

  • Experimental: HAI oxaliplatin combined with I.V. FOLFIRI + target therapy
    * HAI oxaliplatin 100 mg/m² on D1 * I.V. cetuximab 500 mg/m² or panitumumab 6 mg/kg or bevacizumab 5 mg/kg D1 according to RAS status and prior response/tolerance to systemic induction CT * modified FOLFIRI regimen without fluorouracil bolus * I.V. irinotecan 180 mg/m² D1 * I.V. bolus 5-Fluorouracil (5-FU): 0 * I.V. leucovorin 400 mg/m² in 2 hours D1 * I.V. continuous infusion 5-FU 2400 mg/m² in 46 hours
  • Active Comparator: conventional systemic CT
    * Response to systemic induction CT * Toxicity and duration of the systemic induction CT * RAS status * Current guidelines/standard of care

Primary Outcome Measure

Curative-intent (R0-R1) resection (and/or ablation) rate (CRR) of CRLM [ Time Frame: 6 months ]

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