Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 8:56 PM
Study NCT ID:
NCT01977235
Status:
UNKNOWN
Last Update Posted:
2016-04-01
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer
Sponsor:
Third Military Medical University
Organization:
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 1A1(UGT1A1)is related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene \*28 (6/6 and 6/7) and \*6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene \*28 (7/7) and \*6 (A/A)is 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 (6/6 and 6/7)and \*6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene \*28 (7/7) and \*6 (A/A)is 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 (6/6 and 6/7)\*6 (G/G and G/A).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: