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

March 29, 2016 updated by: Hoffmann-La Roche

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

563

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer receiving Xeloda

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Capecitabine
Participants will receive capecitabine 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.
Drug: Capecitabine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25281

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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