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

NCT ID: NCT01664494

Last Updated: 2016-05-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

563 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Breast Cancer, Colorectal Cancer, Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Capecitabine

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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ML25281

Identifier Type: -

Identifier Source: org_study_id

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