- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01697449
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)
September 15, 2015 updated by: Hoffmann-La Roche
This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer.
Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
191
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belgrade, Serbia, 11000
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Belgrade, Serbia, 11080
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Kragujevac, Serbia, 34000
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NIS, Serbia, 18000
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Sremska Kamenica, Serbia, 21204
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with metastatic colorectal cancer initiated on Avastin in combination with chemotherapy
Description
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Metastatic colorectal cancer
- Prescribed to receive Avastin according to registered indication
Exclusion Criteria:
- Patients not eligible for Avastin treatment according to the Summary of Product Characteristics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With At Least One Adverse Event (AE)
Time Frame: Up to 65 months
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
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Up to 65 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Up to 65 months
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Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
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Up to 65 months
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Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline
Time Frame: Up to 65 months
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Up to 65 months
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Percentage of Participants With Disease Progression or Death
Time Frame: Up to 65 months
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Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
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Up to 65 months
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Progression Free Survival (PFS)
Time Frame: Up to 65 months
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PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause.
Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment.
Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
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Up to 65 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
September 28, 2012
First Submitted That Met QC Criteria
September 28, 2012
First Posted (Estimate)
October 2, 2012
Study Record Updates
Last Update Posted (Estimate)
October 16, 2015
Last Update Submitted That Met QC Criteria
September 15, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML21889
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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