Completed
Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Over 18 Years
+4 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: July 2009
Summary
Principal SponsorHoffmann-La Roche
Last updated: January 26, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2009
Actual date on which the first participant was enrolled.This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.
Principal SponsorHoffmann-La Roche
Last updated: January 26, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
258 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms
Criteria
3 inclusion criteria required to participate
Adult patients, >= 18 years of age
Metastatic colorectal cancer
Receiving Xeloda according to registered indication
1 exclusion criteria prevent from participating
Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Completed5 Study Centers