Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
Italian, multicentre, non comparative trial in patients with advanced Colorectal
Cancer(CRC)and KRAS wild-type, defined by molecular evaluation.
Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity
developed or patient refusal.
The aim of this study is to assess the prognostic role of PTEN in terms of Progression free
survival.
Although the role of Cetuximab as first line treatment in metastatic CRC will be soon
established, it is still unclear which is the best schedule for Cetuximab and the role of
biological factors in order to select the most appropriate subset of pts for recommending
Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the
perspective to study the role of other molecular markers in this subset of pts.
On the basis of these considerations this study is aimed at testing a different schedule of
Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.
Phase:
Phase 2
Details
Lead Sponsor:
Regione Lombardia
Collaborators:
A.O. Ospedale Papa Giovanni XXIII Istituto Clinico Humanitas Mario Negri Institute for Pharmacological Research