Non-Interventional Study of Xeloda (Capecitabine) in Patients With Gastric Cancer

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT02274376
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will collect prospective data on the safety and tolerability of Xeloda in patients with advanced gastric cancer from every day clinical practice. Documentation of treatment for each patient is to continue until the end of treatment per oncologist's assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

• Patients aged >/=18 years, with metastatic gastric cancer who are available for prospective documentation of their treatment (first-line chemotherapy)
• Informed consent

Exclusion Criteria

• Contraindications to Xeloda per the Summary of Product Characteristics (SmPC)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 4 years
Safety and tolerability: incidence and nature of adverse drug reactions	Up to 4 years

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with modifications in Xeloda dosing	Up to 4 years
Average duration of treatment	Up to 4 years
Number of modifications in chosen regimen combination therapy	Up to 4 years
Incidence and nature of dose interruptions	Up to 4 years