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

Colorectal Cancer Clinical Trial

Official title:

A Multicenter, Non-interventional, Post-authorization Study to Observe in Daily Clinical Practice the Treatment Duration of Patients Treated With Avastin (Bevacizumab) in 1st Line mCRC in Belgium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089413
• Other study ID #: ML25117
• Status: Completed
• Phase: N/A
• First received: March 15, 2010
• Last updated: November 13, 2015
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
As prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to end of treatment (up to approximately 3 years)	No
Secondary	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.	Baseline up to disease progression or death (up to approximately 3 years)	No
Secondary	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.	Baseline up to disease progression or death (up to approximately 3 years)	No
Secondary	Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status	ECOG performance status measured on a 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported.	Baseline up to Cycle 51 (1 cycle = 21 days)	No