Viewing Study NCT01474187



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Last Modification Date: 2024-10-26 @ 10:43 AM
Study NCT ID: NCT01474187
Status: UNKNOWN
Last Update Posted: 2011-11-18
First Post: 2011-11-11

Brief Title: Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage IIIII Rectal Cancer
Sponsor: Fudan University
Organization: Fudan University

Study Overview

Official Title: Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage IIIII Rectal Cancer
Status: UNKNOWN
Status Verified Date: 2011-11
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: Irinotecan is one of effective drugs for colorectal cancer In neoadjuvant chemoradiotherapy CRT Irinotecan is prescribed in a low dose of 50mgm2week because of toxicity Some current studies showed that irinotecans dose can be increased significantly for those patients with 66 or 67 genotype of UGT1A1 therefore the investigators designed this trial to explore the maximal tolerable dose MTD of Irinotecan in combined neoadjuvant CRT
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