Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01826396
Status:
UNKNOWN
Last Update Posted:
2013-04-08
First Post:
2013-04-04
Brief Title:
Standard and High Dose Irinotecan Based on UGT1A1 Genotype for First-line Treatment of Locally Advanced Colon Cancer
Sponsor:
Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences
Organization:
Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2013-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 UGT1A128 homozygous variant genotypes was significantly lower compared with the wild genotype The studies based on Asian patients suggested that the gene variant of UGT1A16 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None