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 study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 10, 2012
Last updated: October 1, 2015
Last verified: October 2015
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.

Breast Cancer, Colorectal Cancer, Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional Trial of Xeloda in Metastatic Colorectal Cancer, Adjuvant Colon Cancer, Advanced Gastric Cancer and Breast Cancer

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of treatment cycles in routine clinical practice [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean dosage over all indications [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 664
Study Start Date: April 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer receiving Xeloda

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01664494

Wien, Austria, 1090
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01664494     History of Changes
Other Study ID Numbers: ML25281 
Study First Received: August 10, 2012
Last Updated: October 1, 2015
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Breast Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Skin Diseases
Stomach Diseases processed this record on February 10, 2016