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

Completed

• Conditions: Breast Cancer, Colorectal Cancer, Gastric Cancer
• Interventions: Drug: Capecitabine

• Registration Number: NCT01664494
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-14
• Results First Submitted: 2015-11-19
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-29
• Last Update Submitted: 2016-03-29
• Results First Posted: 2016-05-02
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 563

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

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Exclusion Criteria

• Contraindications according to label and off-label use

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Capecitabine	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment	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 Outcome Measures

Name	Time	Method
Median Dose of Capecitabine	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.