An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer

This multi-center observational study will evaluate the use of Xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving treatment with Xeloda according to product label will be followed for up to 10 months.

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Key information

Conditions

Breast Cancer, Colorectal Cancer, Gastric Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer who are candidates for receiving Xeloda according to product label

Exclusion criteria

Contraindications according to label and off-label use

Treatment and study plan

Capecitabine

Drug

Capecitabine will be given according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.

Primary outcomes

Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment

Time frame: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first

Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.

Secondary outcomes

Median Dose of Capecitabine

Time frame: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first

Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Non-Interventional Trial of Xeloda in Metastatic Colorectal Cancer, Adjuvant Colon Cancer, Advanced Gastric Cancer and Breast Cancer

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Aug 14, 2012
Registry last updated: May 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.

Published trials that share one or more normalized conditions with this study.

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