Colorectal Cancer Clinical Trial
Official title:
CONCEPT - Phase IV, Randomized, Prospective, Multicenter Comparison of Intermittent Schedule of Oxaliplatin Combined With FOLFOX/Bevacizumab vs Conventional Mode of Administration of FOLFOX/Bevacizumab + Neuroprophylaxis With Calcium/Magnesium for Optimization of First-Line Therapy of Metastatic Colorectal Cancer
The primary rationale for this study is to develop an optimized schedule of administration
of FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when
administered to patients with advanced colorectal cancer. The hypothesis is that the use of
an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow these patients to
continue on treatment for a longer period of time by reducing the proportion of patients who
discontinue therapy early because of treatment-related toxicities and thus increasing the
possibility of a longer time to progression.
The primary objective is:
- To test the hypothesis that an intermittent oxaliplatin (IO) schedule of
FOLFOX/bevacizumab will allow patients to remain on therapy for a longer period of time
compared to a conventional "treat-to-failure" schedule, by reducing the proportion of
patients who discontinue therapy for treatment-related toxicities.
The secondary objectives are:
- To evaluate the impact of calcium/magnesium infusions on the incidence and severity of
neurotoxicity in subjects receiving either the IO or conventional FOLFOX/bevacizumab
treatment schedules as first-line treatment for metastatic colorectal cancer.
- To evaluate the safety and efficacy of the IO versus the conventional schedule +
calcium and magnesium infusions, as part of oxaliplatin-based first-line therapy for
metastatic colorectal cancer.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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