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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02479217 |
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Date of registration:
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27/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety of Xeloda in Solid Tumours
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Scientific title:
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Safety of Xeloda in Solid Tumours |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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1268 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02479217 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Metastatic Breast Cancer:
- women >=18 years of age
- Patients with locally advanced or metastatic breast cancer after failure of cytotoxic
chemotherapy.
- Previous therapy should have included an anthracycline.
- Patients with locally advanced or metastatic breast cancer after failure of taxanes
and an anthracycline-containing chemotherapy regimen or for whom further anthracycline
therapy is not indicated.
- Female patients with histopathologically proven metastatic breast cancer
- Adequate bone marrow, liver, renal and cardiac functions
Colon Cancer:
- Patients >18 years of age
- Patients with histologicaly confirmed colon cancer
- Patients with potential curative tumor resection within 8 weeks before enrolment in
the study
- Patients previously not treated with chemiotherapy
Exclusion Criteria:
Metastatic Breast Cancer:
- Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda)
- Patients with contraindications for any of study drugs as listed in approved SmPC
Colon Cancer:
- Patients previously treated with chemiotherapy
- Patients with contraindications for study drug as listed in approved SmPC
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer, Colon Cancer
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Intervention(s)
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Drug: Docetaxel
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Drug: Xeloda
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Primary Outcome(s)
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Number of Participants with Adverse Events
[Time Frame: within 18 months]
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Secondary Outcome(s)
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Disease free survival (DFS)
[Time Frame: within 18 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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