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

Gastric Cancer Clinical Trial

Official title:

NIS Xeloda in Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274376
• Other study ID #: ML21556
• Status: Completed
• Phase: N/A
• First received: October 3, 2014
• Last updated: November 1, 2016
• Start date: August 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		Up to 4 years	No
Primary	Safety and tolerability: incidence and nature of adverse drug reactions		Up to 4 years	No
Secondary	Proportion of patients with modifications in Xeloda dosing		Up to 4 years	No
Secondary	Average duration of treatment		Up to 4 years	No
Secondary	Number of modifications in chosen regimen combination therapy		Up to 4 years	No
Secondary	Incidence and nature of dose interruptions		Up to 4 years	No