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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01089413
First received: March 15, 2010
Last updated: November 13, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Colorectal Cancer
Drug: bevacizumab [Avastin]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Duration of Bevacizumab Treatment [ Time Frame: Baseline up to end of treatment (up to approximately 3 years) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to disease progression or death (up to approximately 3 years) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Best Overall Response [ Time Frame: Baseline up to disease progression or death (up to approximately 3 years) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline up to Cycle 51 (1 cycle = 21 days) ] [ Designated as safety issue: No ]
    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.


Enrollment: 201
Study Start Date: January 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: bevacizumab [Avastin]
As prescribed by physician

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with 1st line treatment with bevacizumab in Belgium
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089413

Locations
Belgium
Aalst, Belgium, 9300
Antwerpen, Belgium, 2020
Assebroek, Belgium, 8310
AYE, Belgium, 6900
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01089413     History of Changes
Other Study ID Numbers: ML25117 
Study First Received: March 15, 2010
Results First Received: November 13, 2015
Last Updated: November 13, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 27, 2016