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

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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: bevacizumab [Avastin]

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• Belgium
  • AYE, Belgium, 6900
  • Aalst, Belgium, 9300
  • Antwerpen, Belgium, 2020
  • Assebroek, Belgium, 8310
  • Brugge, Belgium, 8000
  • Bruxelles, Belgium, 1180
  • Charleroi, Belgium, 6000
  • Haine-saint-paul, Belgium, 7100
  • Hasselt, Belgium, 3500
  • Ieper, Belgium, 8900
  • Kortrijk, Belgium, 8500
  • Liege, Belgium, 4000
  • Mons, Belgium, 7000
  • Namur, Belgium, 5000
  • Roeselare, Belgium, 8800
  • Sint-Niklaas, Belgium, 9100
  • Tongeren, Belgium, 3700
  • Tournai, Belgium, 7500
  • Vilvoorde, Belgium, 1800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with 1st line treatment with bevacizumab in Belgium

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort	Drug: bevacizumab [Avastin]; As prescribed by physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 17, 2010
• First Posted (Estimate): March 18, 2010

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: ML25117