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

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ClinicalTrials.gov Identifier: NCT01555762
Recruitment Status : Completed
First Posted : March 15, 2012
Results First Posted : January 21, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease
Colorectal Cancer

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Study Type : Observational
Actual Enrollment : 402 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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.
Actual Study Start Date : March 5, 2012
Actual Primary Completion Date : July 20, 2016
Actual Study Completion Date : July 20, 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elderly patients with metastatic colorectal cancer initiating first-line treatment with Avastin
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555762


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01555762     History of Changes
Other Study ID Numbers: ML27829
First Posted: March 15, 2012    Key Record Dates
Results First Posted: January 21, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors