Viewing Study NCT00398398



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00398398
Status: COMPLETED
Last Update Posted: 2020-01-07
First Post: 2006-11-09

Brief Title: Study of XELOX With Cetuximab in Advanced Gastric Cancer
Sponsor: Asan Medical Center
Organization: Asan Medical Center

Study Overview

Official Title: A Prospective Phase II Study of Cetuximab Erbitux in Combination With XELOX XELoda Capecitabine and OXaliplatin in Patients With Advanced Gastric Cancer
Status: COMPLETED
Status Verified Date: 2020-01
Last Known Status: None
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: The combination of capecitabine and oxaliplatin as backbone regimen adding a newer biologic agent cetuximab is a reasonable strategy of further chemotherapy development in advanced gastric cancer which is the investigators study rationale
Detailed Description: There is presently no chemotherapy regimen considered to be the global standard of care for patients with AGC and there is still a need for new agents andor regimens to improve the efficacy and safety of chemotherapy in advanced stomach cancers

The combination of 5-fluorouracil plus cisplatin FP has been widely used for the first-line treatment of advanced gastric cancer in many countries

Randomized phase III trial investigating capecitabine plus cisplatinXP versus FP showed XP is at least as good as FP with improved patients preference

A Phase II study of capecitabine plus oxaliplatin XELOX was conducted in our study group

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
Secondary IDs
Secondary ID Type Domain Link
EMR 62202-723OXALI_L_01600 None None None