Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)

Hoffmann-La Roche201 enrolled

Overview

This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab \[Avastin\] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is \>300 patients.

Study Type

OBSERVATIONAL

Enrollment

201

Conditions

Colorectal Cancer

Interventions

bevacizumab [Avastin]DRUG

As prescribed by physician

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients =/\<18 years of age * metastatic colorectal cancer * patients for whom the physician has prescribed bevacizumab \[Avastin\] for the treatment of 1st line metastatic colorectal cancer * patients, who have given written informed consent Exclusion Criteria: * hypersensitivity to recombinant human or humanised antibodies * pregnancy or breast-feeding

Locations (19)

Unnamed facility

Aalst, Belgium

Unnamed facility

Antwerp, Belgium

Unnamed facility

Assebroek, Belgium

Outcomes

Primary Outcomes

Duration of Bevacizumab Treatment

Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus \[+\] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and greater than or equal to \[≥\] 70 years) as well as for overall participants.

Time frame: Baseline up to end of treatment (up to approximately 3 years)

Secondary Outcomes

Progression-Free Survival (PFS)

PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and ≥70 years) as well as for overall participants.

Time frame: Baseline up to disease progression or death (up to approximately 3 years)

Percentage of Participants With Best Overall Response

Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (\<70 years, 70-80 years, and \>80 years) as well as for overall participants.

Data from ClinicalTrials.gov

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