Viewing Study NCT00509964



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Study NCT ID: NCT00509964
Status: UNKNOWN
Last Update Posted: 2007-08-01
First Post: 2007-07-31

Brief Title: Second-Line Irinotecan vs ILF for AGC
Sponsor: Gachon University Gil Medical Center
Organization: Gachon University Gil Medical Center

Study Overview

Official Title: A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan Leucovorin and 5-FU ILF Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy
Status: UNKNOWN
Status Verified Date: 2007-07
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: Patients with recurrent or metastatic gastric cancer can benefit from palliative chemotherapy However over half of patients with metastatic gastric cancer who received chemotherapy failed to achieve response and even in these responders the duration of responses was as short as a few months Patients with metastatic gastric cancer who fail to respond or have relapse after first line chemotherapy have a grim prognosis and a standard salvage treatment is not available

We designed this phase II trial to determine the efficacy and safety of irinotecan monotherapy or combination ILF as second-line therapy for advanced gastric cancer
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