Colorectal Cancer Metastatic Clinical Trial
Official title:
A Phase IV Multicenter Trial to Evaluate Real-world Health Outcomes, Economic Impact and Resistance Mechanisms of Panitumumab in the Treatment of Patients With Chemotherapy-refractory Metastatic Colorectal Cancer
This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact
and resistance mechanisms of panitumumab in the treatment of patients with
chemotherapy-refractory metastatic colorectal cancer (mCRC).
This study will address two anticipated issues surrounding personalized medicine and
treatment with panitumumab. First, it will enable to assess the economic impact of
panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based
mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic
colorectal cancer (Blood study).
The primary objective is to collect information on quality of life and health care resource
utilization by patients diagnosed with metastatic colorectal cancer. The secondary objectives
are to confirm survival data, to assess the quality of life of patients and to assess the
health care resource utilization of patients. The blood biomarker study objective is to
determine blood-based biomarkers of response or resistance to panitumumab.
Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will
participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will be
treated with panitumumab and will participate to the HEOR study and to the blood biomarker
study.
During the course of the study, data will be collected on quality of life and work
productivity. Patients will be asked to fill a set of questionnaires at their recruitment in
the study and at every 3 months after treatment initiation. For patients participating to the
blood study (patients with a wild type KRAS), blood samples will be collected before patients
start their treatment, at every treatment and when they discontinue their treatment.
n/a
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