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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 has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 27, 2012
Last updated: November 1, 2016
Last verified: November 2016
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).

Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 256
Study Start Date: August 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01676922

Aalst, Belgium, 9300
Antwerpen, Belgium, 2020
Assebroek, Belgium, 8310
Bonheiden, Belgium, 2820
Bornem, Belgium, 2880
Brasschaat, Belgium, 2930
Brugge, Belgium, 8000
Brussel, Belgium, 1090
Bruxelles, Belgium, 1070
Bruxelles, Belgium, 1200
Gent, Belgium, 9000
Haine-Saint-Paul, Belgium, 7100
Hasselt, Belgium, 3500
Hornu, Belgium, 7301
Ieper, Belgium, 8900
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Lier, Belgium, 2500
Liège, Belgium, 4000
Mechelen, Belgium, 2800
Mons, Belgium, 7000
Mont-godinne, Belgium, 5530
Namur, Belgium, 5000
Oostende, Belgium, 8400
Oudenaarde, Belgium, 9700
Roeselare, Belgium, 8800
Ronse, Belgium, 9600
Seraing, Belgium, 4100
Sint-Niklaas, Belgium, 9100
Tongeren, Belgium, 3700
Turnhout, Belgium, 2300
Verviers, Belgium, 4800
Wilrijk, Belgium, 2610
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01676922     History of Changes
Other Study ID Numbers: ML27768
Study First Received: August 27, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on May 25, 2017