An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01676922

First received: August 27, 2012

Last updated: November 1, 2016

Last verified: November 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

August 27, 2012

Last Updated Date

November 1, 2016

Start Date ^ICMJE

August 2011

Primary Completion Date

May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01676922 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ]
Safety: Incidence of adverse events/adverse events of special interest [ Time Frame: approximately 24 months ]
Clinical/demographic patient characteristics at baseline [ Time Frame: approximately 24 months ]
Dosage/regimen [ Time Frame: approximately 24 months ]
Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment [ Time Frame: approximately 24 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

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 ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

256

Completion Date

May 2015

Primary Completion Date

May 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

70 Years and older (Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium

Removed Location Countries

Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT01676922

Other Study ID Numbers ^ICMJE

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 ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

PRS Account

Hoffmann-La Roche

Verification Date

November 2016

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

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