An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01676922
First received: August 27, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This observational study will evaluate the use of Avastin (bevacizumab) and conventional chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal cancer. Data will be collected from each patient from initiation of treatment until disease progression occurs (minimum follow-up 12 months).
| Condition |
|---|
|
Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Non-interventional Study to Collect Data on the Use of Avastin and Conventional Chemotherapy for the Treatment of Previously Untreated Metastatic Colorectal Cancer in Patients >/= 70 Years |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events/adverse events of special interest [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Clinical/demographic patient characteristics at baseline [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Dosage/regimen [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients >/= 70 years of age with previously untreated metastatic colorectal cancer suitable to receive chemotherapy with or without Avastin
Criteria
Inclusion Criteria:
- Adult patients, >/ 70 years of age
- Previously untreated metastatic colorectal cancer
- Patient considered suitable to receive chemotherapy with or without Avastin
Exclusion Criteria:
- Participation in any other clinical trial or study with the exception of participation in registries
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676922
Contacts
| Contact: Please reference Study ID Number: ML27768 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Belgium | |
| Recruiting | |
| Aalst, Belgium, 9300 | |
| Recruiting | |
| Antwerpen, Belgium, 2020 | |
| Recruiting | |
| Assebroek, Belgium, 8310 | |
| Recruiting | |
| Bonheiden, Belgium, 2820 | |
| Recruiting | |
| Bornem, Belgium, 2880 | |
| Recruiting | |
| Brasschaat, Belgium, 2930 | |
| Recruiting | |
| Brugge, Belgium, 8000 | |
| Recruiting | |
| Bruxelles, Belgium, 1090 | |
| Recruiting | |
| Bruxelles, Belgium, 1200 | |
| Recruiting | |
| Bruxelles, Belgium, 1070 | |
| Recruiting | |
| Gent, Belgium, 9000 | |
| Recruiting | |
| Haine-saint-paul, Belgium, 7100 | |
| Completed | |
| Hasselt, Belgium, 3500 | |
| Recruiting | |
| Hornu, Belgium, 7301 | |
| Recruiting | |
| Ieper, Belgium, 8900 | |
| Recruiting | |
| Kortrijk, Belgium, 8500 | |
| Recruiting | |
| Leuven, Belgium, 3000 | |
| Recruiting | |
| Liege, Belgium, 4000 | |
| Recruiting | |
| Lier, Belgium, 2500 | |
| Recruiting | |
| Mechelen, Belgium, 2800 | |
| Recruiting | |
| Mons, Belgium, 7000 | |
| Terminated | |
| Mont-godinne, Belgium, 5530 | |
| Terminated | |
| Namur, Belgium, 5000 | |
| Recruiting | |
| Oostende, Belgium, 8400 | |
| Recruiting | |
| Oudenaarde, Belgium, 9700 | |
| Recruiting | |
| Roeselare, Belgium, 8800 | |
| Recruiting | |
| Ronse, Belgium, 9600 | |
| Recruiting | |
| Seraing, Belgium, 4100 | |
| Recruiting | |
| Sint-niklaas, Belgium, 9100 | |
| Recruiting | |
| Tongeren, Belgium, 3700 | |
| Recruiting | |
| Turnhout, Belgium, 2300 | |
| Recruiting | |
| Verviers, Belgium, 4800 | |
| Recruiting | |
| Wilrijk, Belgium, 2610 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01676922 History of Changes |
| Other Study ID Numbers: | ML27768 |
| Study First Received: | August 27, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on May 16, 2013