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NCT Number: NCT01791140

BEVERLY-C: An Observational Study of Avastin (Bevacizumab) in First-Line Treatment in Elderly Patients With Metastatic Colorectal Cancer

This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy in elderly patients (>/= 65 years of age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until disease progression, death, withdrawal of consent, discontinuation of physician-patient relationship or study closure, whichever comes first.

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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

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Budapest, 1145, Hungary

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 65 years of age
  • Patients with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy according to the approved Hungarian Summary of Product Characteristics
  • Patients suitable for Avastin treatment as assessed by the treating physician

Exclusion criteria

  • Any contraindications to Avastin treatment according to the Hungarian Summary of Product Characteristics

Treatment and study plan

Primary outcomes

  1. Median progression-free survival

    Time frame: approximately 3.5 years

Secondary outcomes

  1. Overall response rate (complete response + partial response)

    Time frame: approximately 3.5 years

  2. Clinical benefit rate (complete response + partial response + stable disease)

    Time frame: approximately 3.5 years

  3. Metastasectomy rate

    Time frame: approximately 3.5 years

  4. Mean duration of Avastin treatment

    Time frame: approximately 3.5 years

  5. Safety: Incidence of adverse events

    Time frame: approximately 3.5 years

  6. Median progression-free survival in subgroup receiving Avastin plus fluorouracil monotherapy

    Time frame: approximately 3.5 years

  7. Median progression-free survival according to age group (65-74 years; >/= 75 years)

    Time frame: approximately 3.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Program for Assessment of Activity and Safety of 1st-line Bevacizumab (Avastin) Therapy in Elderly Patients With Metastatic Colorectal Cancer (BEVERLY-C Study)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 13, 2013
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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