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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||402 participants|
|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|
- 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.
- 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.
- Percentage of Participants With Bevacizumab Administration [ Time Frame: Up to 36 months ]
- 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.
- 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.
- 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.
- 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.
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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|Study Director:||Clinical Trials||Hoffmann-La Roche|