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Completed

NCT Number: NCT01555762

An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE)

This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch D Abbeville; Medecine B1, Abbeville, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 75 years of age
  • Metastatic colorectal cancer
  • Initiating Avastin first-line therapy in combination with chemotherapy

Exclusion criteria

  • Previous Avastin therapy
  • Patient participating in a clinical study evaluating a cytotoxic anti-cancer therapy and/or an investigational new drug

Treatment and study plan

Primary outcomes

  1. Progression-Free Survival

    Time frame: From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)

    Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary outcomes

  1. Overall Survival

    Time frame: From the time of first dose of study treatment to the time of death from any cause (Up to 53 months)

    Overall survival was defined as the time between the treatment start date (date of the first infusion of bevacizumab) and date of all-cause death.

  2. Percentage of Participants With Bevacizumab Administration

    Time frame: Up to 36 months

  3. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to 53 months

    An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

  4. Percentage of Participants With Activities of Daily Living (ADL)

    Time frame: Baseline, Month 6, 12, 24

    The Katz Activity of Daily Living (ADL) questionnaire scale contains 6 items evaluating in terms of autonomy or dependence the patient's ability to carry out basic activities of daily living (bathing, dressing, toileting, transfer, continence, feeding). Total score range 0 (low) to 6 (high). High score indicates participant is independent.

  5. Lawton Instrumental Activities of Daily Living Score (IADL)

    Time frame: Baseline, Month 6, 12, 24

    The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a participant is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale (telephone use, shopping, cooking, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances). Participants are scored according to their level of functioning from 0 (low function, dependent) to 8 (high function, independent). Higher score for each domain represents better functional performance of the older people.

  6. Percentage of Participants With Balducci Score

    Time frame: Baseline, Month 6, 12, 24

    Balducci score defines an algorithm for the individual participant according to age, ADL and modified IADL 4-items scores, estimated performance status and comorbidities, particularly cardiovascular, cancer, depression or anemia. Balducci score is categorized in the following- Type 1 (Harmonious), Type 2 (Intermediate) and Type 3 (Frail). Type 1 indicates better results and Type 3 indicates worse outcomes.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer.

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2012
Registry last updated
Mar 5, 2019

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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