Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)
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| ClinicalTrials.gov Identifier: NCT01089413 |
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Recruitment Status :
Completed
First Posted : March 18, 2010
Results First Posted : December 16, 2015
Last Update Posted : December 16, 2015
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Cancer | Drug: bevacizumab [Avastin] |
| Study Type : | Observational |
| Actual Enrollment : | 201 participants |
| 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 |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | June 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Bevacizumab
| Group/Cohort | Intervention/treatment |
|---|---|
| Cohort |
Drug: bevacizumab [Avastin]
As prescribed by physician |
Primary Outcome Measures :
- Duration of Bevacizumab Treatment [ Time Frame: Baseline up to end of treatment (up to approximately 3 years) ]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) ]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) ]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) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01089413 |
| Other Study ID Numbers: |
ML25117 |
| First Posted: | March 18, 2010 Key Record Dates |
| Results First Posted: | December 16, 2015 |
| Last Update Posted: | December 16, 2015 |
| Last Verified: | November 2015 |
Additional relevant MeSH terms:
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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 Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |