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

NIS Xeloda in Gastric Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02274376

Enrollment

223

Registered

2014-10-24

Start date

2008-08-31

Completion date

2012-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results