Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03329183
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2017-10-25
Brief Title:
High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A16 and 28
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
High-dose FOLFIRI Versus Standard-dose FOLFIRI or FOLFOX-6 in Advanced Colorectal Cancer Patients With Wild-type UGT1A16 and 28 A Randomized Opened Phase II Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2019-02
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:
This trial aims to evaluate the efficacy safety of high-dose FOLFIRI regimen in advanced colorectal cancer patients with wild-type UGT1A16 and 28
Detailed Description:
Pharmacogenetic testing of uridine diphosphate glucuronosyltransferase 1A1 UGT1A1 628 is recommended in clinical practice prior to the administration of irinotecan CPT-11-based regimens such as FOLFIRI regimen in patients with advanced colorectal cancer To avoid severe toxicity of irinotecan such as severe neutropenia and diarrhea patients with UGT1A1 628 mutation often start with a reduced dose of irinotecan However it remains unclear whether high-dose CPT-based regimen FOLFIRI could increase clinical efficacy in CRC patients when compared with standard-dose FOLFIRI or FOLFOX-6 regimens This trial aims to compare the efficacy safety of high-dose FOLFIRI and standard-dose FOLFIRI or FOLFOX-6 in advanced colorectal cancer patients with UGT1A16 GG and 28 TA66
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None