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NCT Number: NCT01676922

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

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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice

    Time frame: approximately 24 months

Secondary outcomes

  1. Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice

    Time frame: approximately 24 months

  2. Safety: Incidence of adverse events/adverse events of special interest

    Time frame: approximately 24 months

  3. Clinical/demographic patient characteristics at baseline

    Time frame: approximately 24 months

  4. Dosage/regimen

    Time frame: approximately 24 months

  5. Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment

    Time frame: approximately 24 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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