Trial Comparing Two Two Sequences of Therapy in Colorectal Metastatic Patients
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
Aim of this study is to compare the efficacy and safety of two different sequences of
chemotherapeutic agents in order to optimize the treatment of patients with metastatic
colorectal cancer progressed to a first line chemotherapy with FOLFIRI and bevacizumab.
Primary endpoint will be overall survival, defined as the time elapsed from the date of
randomization to the date of patient death due to any cause, or the last date the patient was
known to be alive.
Secondary Objectives Progression free survival, Quality of life, Health resource utilisation
and economic evaluation, Toxicity and incidence of adverse events
The study regimen includes:
Strategy A: FOLFOX-4 followed, after progression, by irinotecan/cetuximab Strategy B:
irinotecan/cetuximab followed, after progression, by FOLFOX-4 Patients will be randomly
assigned to one of the two treatment sequences (with 1:1 ratio) using a block design
randomization procedure stratified according to center.
The patient accrual period is planned for approximately 36 months. To assess OS, all pts will
be followed for up to 18 months after the last patient is randomised. The maximum estimated
study duration is approximately 54 months.All statistical analyses will be based on an
intention-to-treat approach. CONSORT rules will be applied to describe study flow and
protocol deviations.
Phase:
Phase 3
Details
Lead Sponsor:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente