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Completed

NCT Number: NCT02274376

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: Up to 4 years

  2. Safety and tolerability: incidence and nature of adverse drug reactions

    Time frame: Up to 4 years

Secondary outcomes

  1. Proportion of patients with modifications in Xeloda dosing

    Time frame: Up to 4 years

  2. Average duration of treatment

    Time frame: Up to 4 years

  3. Number of modifications in chosen regimen combination therapy

    Time frame: Up to 4 years

  4. Incidence and nature of dose interruptions

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

NIS Xeloda in Gastric Cancer

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 24, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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