Viewing Study NCT01977235



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Last Modification Date: 2024-10-26 @ 11:14 AM
Study NCT ID: NCT01977235
Status: UNKNOWN
Last Update Posted: 2016-04-01
First Post: 2013-10-15

Brief Title: Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer
Sponsor: Third Military Medical University
Organization: Third Military Medical University

Study Overview

Official Title: An Open Randomized Parallel Control Multiple-center Phase II Trial of Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer
Status: UNKNOWN
Status Verified Date: 2016-03
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: TDICC
Brief Summary: As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1UGT1A1is related to the side effect of diarrhea induced by irinotecan UGT1A1 gene 28 66 and 67 and 6 GG and GA is related to low probability of diarrhea and UGT1A1 gene 28 77 and 6 AAis related to high probability of diarrhea The purpose of this study is to find out the efficacy and side effect between two different dosages of irinotecan combined with cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene 28 66 and 67and 6 GG and GA based on the hypothesis that the UGT1A1 gene 28 77 and 6 AAis few in the Chinese population and increasing the dose of irinotecan can improve the efficacy without increasing the side effect in the patients with UGT1A1 gene 28 66 and 676 GG and GA
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