Colonic Neoplasms Clinical Trial
Official title:
Comparison of Standard and High Dose Irinotecan Based on UGT1A1 Genotype, 5-fluorouracil, and Leucovorin (FOLFIRI) for First-line Treatment of Locally Advanced Colon Cancer: a Prospective Phase II Clinical Study
In the current treatment of colon cancer, the definition of locally advanced colon cancer
(LACC) is controversial, and the clinical trial evidence which support treatment for LACC is
not clear. Irinotecan (CPT-11) combined with fluoropyrimidine (5FU, capecitabine) is main
chemotherapy regimen for patients with advanced colorectal cancer. Whether this regimen also
could be effectively applied for patients with locally advanced colon cancer? It is worthy
of clinicians to conduct research. In recent studies, the literature indicated that the the
uridine diphosphate glucuronide transfer enzyme (UGT1A1) is an important metabolic enzymes
associated with drug metabolism of CPT-11. The gene polymorphism of UGT1A1 is related to
delayed diarrhea and neutropenia caused by irinotecan. Irinotecan dose-exploration study
found that the maximum tolerated dose for irinotecan in patients with UGT1A1*28 homozygous
variant genotypes was significantly lower compared with the wild genotype. The studies based
on Asian patients suggested that the gene variant of UGT1A1*6 also have similar impacts. At
present, the studies of irinotecan dose adjustment based on the UGT1A1 gene polymorphisms
has not yet come to the consistency of conclusions. The frequency of UGT1A1 gene
polymorphisms between different races is significant different, irinotecan dose exploratory
study based on Chinese patients has not been carried out.
This study focus on prospectively adverse reactions, optimal efficacy and R0 resection rate
of the patients with LACC who treated by dose-adjusted irinotecan based on the genotypes of
UGT1A1.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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