The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Not Applicable

Recruiting

• Conditions: Gastrointestinal Cancer; UGT1A1 Gene Mutation; Head and Neck Cancer; Dihydropyrimidine Dehydrogenase Deficiency; Breast Cancer
• Interventions: Other: Availability of clinical decision support based on pharmacogenomic results.

• Registration Number: NCT04541381
• Lead Sponsor: University of Chicago

Brief Summary

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".

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2022-02-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2027-10-01
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacogenomics Group	Availability of clinical decision support based on pharmacogenomic results.	Participants enrolled in the pharmacogenomics group will give a DNA (deoxyribonucleic acid) sample for immediate pharmacogenomic genotyping. Once the genotyping results are in, cancer doctors caring for each participant will have immediate access to clinical decision support based on the participant's genetic results and can make dosing decisions/changes to the participant's chemotherapy prescription.

Primary Outcome Measures

Name	Time	Method
Dose Deviation Rate (Co-Primary Endpoint)	15 months	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.
Grade 3 or Higher Toxicity (Co-Primary Endpoint)	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative Chemotherapy Dose Intensity	5 years.	Cumulative drug dose intensity received (function of dose and frequency of drug administration).
Response Rate	5 years.	Anti-cancer tumor response based on radiographic assessment (complete response, partial response, stable disease, progressive disease), by tumor type and disease setting.
Progression free survival (PFS)	5 years	Progression free survival (PFS) by tumor type and disease setting.
Overall Survival	5 years	Overall survival (OS) by tumor type and disease setting.

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States