Status:
RECRUITING
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Lead Sponsor:
Reema A. Patel
Conditions:
Colorectal Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (\*1/\*...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.
- Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.
- Age ≥ 18 years.
- ECOG performance status ≤ 1.
- Patients must have adequate organ and marrow function as defined below:
- Measurable or non-measurable disease.
Exclusion
- Patients who received prior treatment with irinotecan are excluded.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
- Pregnant women are excluded from this study.
- Patients who are not planned for treatment of their cancer.
Key Trial Info
Start Date :
September 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT05391126
Start Date
September 28 2022
End Date
May 1 2027
Last Update
December 16 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40506