Study of XELOX With Cetuximab in Advanced Gastric Cancer
A Prospective Phase II Study of Cetuximab (Erbitux®) in Combination With XELOX [XELoda® (Capecitabine) and OXaliplatin] in Patients With Advanced Gastric Cancer
Sponsor study identifier
Secondary identifiers
interventional
44
1 country
3
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 9, 2006
Actual (reported)November 10, 2006
Actual (reported)September 2008
Actual (reported)September 2008
Actual (reported)November 2, 2015
Actual (reported)Overall Response Rate
Tumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders.
6 months
Progression-free Survival
1 year
Overall Survival
1 year
Toxicity Profile
1 years
Capecitbine, oxaliplatin and cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.
Xelox(Capecitbine, Oxaliplatin) and Cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Capecitabine, Oxaliplatin, Cetuximab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordAsan Medical Center
Seoul, South Korea
Korea Cancer Center Hospital
Seoul, South Korea
Seoul Samsung Medical Center
Seoul, South Korea
Yoon-Koo Kang, MD, PhD
Asan Medical Center
44 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2006
First Posted
November 10, 2006
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
Contact the study team to confirm eligibility.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
January 7, 2020
Results First Posted
November 2, 2015
Record last verified: 2020-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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