Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320294
Status:
UNKNOWN
Last Update Posted:
2007-03-12
First Post:
2006-05-01
Brief Title:
ILF WithWithout Cisplatin for Advanced Gastric Cancer
Sponsor:
Gachon University Gil Medical Center
Organization:
Gachon University Gil Medical Center
Study Overview
Official Title:
A Randomized Trial of Irinotecan Leucovorin 5-FU ILF Versus ILF Plus Cisplatin PILF Combination Chemotherapy in Patients With Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
ACTIVE_NOT_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:
To compare the combination of irinotecan leucovorin and 5-FU ILF with ILF plus cisplatin PILF as first-line chemotherapy in patients with measurable metastatic gastric cancer
Detailed Description:
Irinotecan in combination with 5-FU or cisplatin clearly demonstrated efficacy against gastric cancer A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42 and a median survival of 107 months which were significantly better than the results with IP regimen Pozzo C et al Ann Oncol 2004 However since cisplatin is still considered one of the key drugs for the treatment of gastric cancer a combination of these four drugs irinotecan leucovorin FU and cisplatin seemed to be a promising strategy for advanced AGC We desinged this randomized phase II study to compare the combination of irinotecan leucovorin and 5-FU ILF with ILF plus cisplatin PILF as first-line chemotherapy in patients with measurable metastatic gastric cancer
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