Metastatic Colorectal Cancer Clinical Trial
Official title:
Phase II Randomized Controlled Trial of FOLFOXIRI Compared to FOLFOX in First Line Treatment of Chemo-naive Metastatic Colorectal Cancer
The purpose of the study is to evaluate if the exposure to all the three active cytotoxic
agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional
chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic
colorectal cancer patients.
A second primary aim is to evaluate the response rate, safety and tolerability of the
chemotherapy of FOLFOXIRI regimen in this patient population.
Patients will be randomized to two therapy groups:
Experimental arm A: Chemotherapy with FOLFOXIRI Standard arm B: Chemotherapy with FOLFOX
Survival of patients with metastatic colorectal cancer is correlated with the proportion of
patients who receive all the three active drugs , but not with the proportion of patients
who receive any second-line therapy. A superior efficacy in PFS,ORR and OS of FOLFOXIRI has
been reported with acceptable toxicity. Moreover,evidence suggests that continuous dosing
metronomic chemotherapy may be more efficacious than interval-chemotherapy.
Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to
administer a maintenance first-line regimen containing the three active agents.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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