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

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT01555762
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2016-07-20
• Study Completion: 2016-07-20
• Results First Submitted: 2017-09-28
• Results First Submitted QC: 2018-07-27
• Results First Posted: 2019-01-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	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

Name	Time	Method
Percentage of Participants With Bevacizumab Administration	Up to 36 months
Percentage of Participants With Adverse Events (AEs)	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)	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.
Overall Survival	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 Balducci Score	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.
Lawton Instrumental Activities of Daily Living Score (IADL)	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.

Trial Locations

Locations (165)

Ch D Abbeville; Medecine B1; 🇫🇷 Abbeville, France

Clinique Du Docteur Calabet; Cromg; 🇫🇷 Agen, France

Ch D Agen; Medecine Interne II; 🇫🇷 Agen, France

C.H. Du Pays D'aix En Provence Service du Dr Blanc; 🇫🇷 Aix En Provence, France

Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire; 🇫🇷 Aix En Provence, France

Chd Castelluccio; Oncologie; 🇫🇷 Ajaccio, France

Clinique Claude Bernard; Onco Hematologie; 🇫🇷 Albi, France

Chi D Alencon; Medecine Ambulatoire; 🇫🇷 Alencon, France

Chi D Alencon; Medecine I; 🇫🇷 Alencon, France

Hopital Nord; Medecine A; 🇫🇷 Amiens, France

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