The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Launched by UNIVERSITY OF CHICAGO · Sep 1, 2020

Keywords

ClinConnect Summary

The PhOCus Trial is a research study designed to explore how sharing genetic information with cancer care providers can help tailor chemotherapy treatments for patients with specific types of cancer, including gastrointestinal cancer, head and neck cancer, breast cancer, and those with certain genetic conditions. The goal is to see if this personalized approach can improve the effectiveness of chemotherapy and reduce common side effects. Participants will be randomly placed in one of two groups: one that receives pharmacogenomic testing and another that does not, allowing researchers to compare the outcomes.

To be eligible for this study, participants must be adults receiving cancer treatment at The University of Chicago Medical Center and planning to use specific chemotherapy drugs called fluoropyrimidines or irinotecan. The trial welcomes individuals of all genders and backgrounds, but there are some exclusions, such as those who have had prior treatment with these drugs or have certain health conditions affecting the liver or kidneys. If you join the trial, you can expect to provide genetic samples and receive personalized information that could influence your chemotherapy treatment. This study aims to enhance cancer care by using genetic insights to make better treatment decisions.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria Adult patients receiving oncology care at The University of Chicago Medical Center, and for whom treatment with a fluoropyrimidine and/or irinotecan is planned are eligible.
• • Individuals of all genders, races and ethnic groups are eligible for this trial. There is no bias towards race, sex, or gender in the clinical trial outlined.
• • Exclusion Criteria
• • 1. Subjects who have previously been exposed to the planned chemotherapy agent at any time (fluoropyrimidine and/or irinotecan).
• • 2. Subjects enrolled in an investigational trial which would preclude dose modifications of fluoropyrimidine and/or irinotecan chemotherapies.
• • 3. Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
• • 4. Subjects with a history of or active blood cancer (e.g., leukemia).
• • 5. Chronic kidney disease, as defined by glomerular filtration rate (GFR) \< 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
• • 6. Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin more than 1.5 mg/dL, aspartate Aminotransferase (AST) and alanine transaminase (ALT) more than 2.5 X upper limit of normal\*. (\*AST and ALT more than 5 X upper limit of normal if hepatic metastases are present).
• • 7. Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.
• • 8. Inability to understand and give informed consent to participate.