Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab. An Italian Trial
Pts meeting eligibility criteria will be registered, providing the availability of material
for molecular analysis. Tumour specimens and blood sample will be collected to perform
genomic, ICH and proteomic analyses in order to identify the molecular characteristics of
tumour.
After the availability of KRAS evaluation, only the data of KRAS wild-type pts will be
collected.
Access to registration system will be allowed via web.
Patients,KRAS wild-type receive:
- Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of
500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with
LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an
intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU
bolus injection on days 1 and 2
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
untill 48 months
Yes
Roberto Labianca, MD
Principal Investigator
Ospedali Riuniti di Bergamo
Italy: The Italian Medicines Agency
2008-007524-25
NCT01068132
April 2009
July 2013
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