An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)
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ClinicalTrials.gov Identifier: NCT01676922 |
Recruitment Status
:
Completed
First Posted
: August 31, 2012
Last Update Posted
: November 2, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | ||||
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First Submitted Date | August 27, 2012 | |||
First Posted Date | August 31, 2012 | |||
Last Update Posted Date | November 2, 2016 | |||
Study Start Date | August 2011 | |||
Actual Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01676922 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS) | |||
Official Title | Prospective Non-interventional Study to Collect Data on the Use of Avastin and Conventional Chemotherapy for the Treatment of Previously Untreated Metastatic Colorectal Cancer in Patients >/= 70 Years | |||
Brief Summary | This observational study will evaluate the use of Avastin (bevacizumab) and conventional chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal cancer. Data will be collected from each patient from initiation of treatment until disease progression occurs (minimum follow-up 12 months). | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients >/= 70 years of age with previously untreated metastatic colorectal cancer suitable to receive chemotherapy with or without Avastin | |||
Condition | Colorectal Cancer | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Cohort | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
256 | |||
Original Estimated Enrollment |
200200 | |||
Actual Study Completion Date | May 2015 | |||
Actual Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 70 Years and older (Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Belgium | |||
Removed Location Countries | Russian Federation | |||
Administrative Information | ||||
NCT Number | NCT01676922 | |||
Other Study ID Numbers | ML27768 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Hoffmann-La Roche | |||
Study Sponsor | Hoffmann-La Roche | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Hoffmann-La Roche | |||
Verification Date | November 2016 |