Safety of Xeloda in Solid Tumours
1 other identifier
observational
1,268
1 country
1
Brief Summary
The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedFebruary 17, 2017
February 1, 2017
2.9 years
May 27, 2015
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events
within 18 months
Secondary Outcomes (1)
Disease free survival (DFS)
within 18 months
Study Arms (3)
Adjuvant therapy
Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer
Combination Therapy
Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression
Monotherapy
Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer
Interventions
Eligibility Criteria
Patients with early or metastatic colon cancer, and patients with metastatic breast cancer, no age limit
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Kamenitz, 21204, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2015
First Posted
June 24, 2015
Study Start
July 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
February 17, 2017
Record last verified: 2017-02