GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

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/\*28) (heterozygotes) and usual UGT metabolizers (\*1/\*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (\*1/\*28, \*1/\*1) will be randomized to genotype-guided dosing versus usual care.

Trial Details

NCT ID
NCT05391126
Phase
NA
Sponsor
Reema A. Patel
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Irinotecan
Locations (sample)
  • Lexington, Kentucky, United States|37.98869,-84.47772

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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