Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01676922
First received: August 27, 2012
Last updated: February 5, 2015
Last verified: February 2015
History of Changes

August 27, 2012
February 5, 2015
August 2011
June 2015   (final data collection date for primary outcome measure)
Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01676922 on ClinicalTrials.gov Archive Site
  • Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events/adverse events of special interest [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at baseline [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Dosage/regimen [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)
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

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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients >/= 70 years of age with previously untreated metastatic colorectal cancer suitable to receive chemotherapy with or without Avastin
Colorectal Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
256
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/ 70 years of age
  • Previously untreated metastatic colorectal cancer
  • Patient considered suitable to receive chemotherapy with or without Avastin

Exclusion Criteria:

  • Participation in any other clinical trial or study with the exception of participation in registries
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Russian Federation
 
NCT01676922
ML27768
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP