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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: November 10, 2014
Last verified: November 2014
  Purpose

This observational study will evaluate the use of Avastin (bevacizumab) and conv entional chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal cancer. Data will be collected from each patient from init iation of treatment until disease progression occurs (minimum follow-up 12 month s).


Condition
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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

Criteria

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 ClinicalTrials.gov identifier: NCT01676922

Locations
Belgium
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, 1200
Bruxelles, Belgium, 1070
Gent, Belgium, 9000
Haine-saint-paul, Belgium, 7100
Hasselt, Belgium, 3500
Hornu, Belgium, 7301
Ieper, Belgium, 8900
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Liege, Belgium, 4000
Lier, Belgium, 2500
Mechelen, Belgium, 2800
Mons, Belgium, 7000
Mont-godinne, Belgium, 5530
Namur, Belgium, 5000
Oostende, Belgium, 8400
Oudenaarde, Belgium, 9700
Roeselare, Belgium, B-8800
Ronse, Belgium, 9600
Seraing, Belgium, 4100
Sint-Niklaas, Belgium, 9100
Tongeren, Belgium, 3700
Turnhout, Belgium, 2300
Verviers, Belgium, 4800
Wilrijk, Belgium, 2610
Russian Federation
Saint-Petersburg, Russian Federation, 198205
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01676922     History of Changes
Other Study ID Numbers: ML27768
Study First Received: August 27, 2012
Last Updated: November 10, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014