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NCT05391126 | RECRUITING | Colorectal Cancer

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

Reema A. Patel

Information provided by (Responsible Party):

Reema A. Patel

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/\*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.

Condition or disease

Colorectal Cancer

Pancreatic Cancer

Intervention/treatment

Irinotecan

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 178 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : GENOCARE: a Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Actual Study Start Date : 2022-09-28
Estimated Primary Completion Date : 2027-05
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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.
  • * Patients must have adequate organ and marrow function as defined below:
  • * Measurable or non-measurable disease.
Exclusion Criteria
  • * 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.
GENOCARE: a Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

Location Details

NCT05391126

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40506