Using genetic testing to personalize chemotherapy for cancer patients
The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care
This study is testing if using genetic information can help doctors give the right chemotherapy dose to cancer patients, making treatment more effective and reducing side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 860 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04541381 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if providing genetic information to cancer care providers can help tailor chemotherapy dosing and reduce side effects for patients with various cancers. Participants will be randomly assigned to either a pharmacogenomics group, which receives genetic insights for treatment decisions, or a control group. The focus is on patients scheduled to receive fluoropyrimidine and/or irinotecan chemotherapy, with the goal of improving treatment outcomes through personalized medicine.
Who should consider this trial
Good fit: Ideal candidates are adult patients receiving oncology care at The University of Chicago Medical Center who are scheduled to receive fluoropyrimidine and/or irinotecan.
Not a fit: Patients who have previously been treated with fluoropyrimidine and/or irinotecan or those with certain medical conditions like chronic kidney disease or active blood cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer chemotherapy treatments for cancer patients.
How similar studies have performed: Other studies have shown promise in using pharmacogenomics to personalize cancer treatment, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Peter H. O'Donnell, MD — University of Chicago
- Study coordinator: Peter H. O'Donnell, MD
- Email: podonnel@medicine.bsd.uchicago.edu
- Phone: 773-834-0936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.