Doctors leading this study hope to find out if giving study participants' genetic information to cancer care providers will help personalize chemotherapy dosing decisions and decrease common chemotherapy side effects. Doctors leading the study will collect genetic information from study participants using pharmacogenomics/genotyping. Pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications. This is a randomized study, which means that participants in this study will be randomly assigned (as if "by flip of a coin") to one of two different groups: a "pharmacogenomics group" or "control group".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
860
Availability of clinical decision support based on pharmacogenomic results. These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
University of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGDose Deviation Rate (Co-Primary Endpoint)
To assess the impact of prospective pharmacogenomic testing on dose intensity deviation rate of chemotherapy during the 1st treatment cycle, comparing control vs. pharmacogenomics-guided arms.
Time frame: 15 months
Grade 3 or Higher Toxicity (Co-Primary Endpoint)
To determine the degree to which providing oncologists with comprehensive pharmacogenomic information impacts the incidence of Grade 3 or worse toxicities in subjects receiving chemotherapy. Toxicities will be assessed by Common Terminology Criteria for Adverse Events version 5.
Time frame: 5 years
Cumulative Chemotherapy Dose Intensity
Cumulative drug dose intensity received (function of dose and frequency of drug administration).
Time frame: 5 years.
Response Rate
Anti-cancer tumor response based on radiographic assessment (complete response, partial response, stable disease, progressive disease), by tumor type and disease setting.
Time frame: 5 years.
Progression free survival (PFS)
Progression free survival (PFS) by tumor type and disease setting.
Time frame: 5 years
Overall Survival
Overall survival (OS) by tumor type and disease setting.
Time frame: 5 years
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