Colorectal CancerNCT01676922
An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 33 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 256 participants
- Where
- 33 sitesBelgium
- Study dates
- Aug 2011to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients >/= 70 years of age with previously untreated metastatic colorectal cancer suitable to receive chemotherapy with or without Avastin
Who may be able to join
- Adult patients, >/ 70 years of age
- Previously untreated metastatic colorectal cancer
- Patient considered suitable to receive chemotherapy with or without Avastin
Who cannot join
- Participation in any other clinical trial or study with the exception of participation in registries
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Belgium33 sites
Study site
Aalst, 9300
Study site
Antwerp, 2020
Study site
Assebroek, 8310
Study site
Bonheiden, 2820
Study site
Bornem, 2880
Study site
Brasschaat, 2930
Study site
Bruges, 8000
Study site
Brussels, 1070
Study site
Brussels, 1090
Study site
Brussels, 1200
Study site
Ghent, 9000
Study site
Haine-Saint-Paul, 7100
Study site
Hasselt, 3500
Study site
Hornu, 7301
Study site
Ieper, 8900
Study site
Kortrijk, 8500
Study site
Leuven, 3000
Study site
Liège, 4000
Study site
Lier, 2500
Study site
Mechelen, 2800
Study site
Mons, 7000
Study site
Mont-godinne, 5530
Study site
Namur, 5000
Study site
Ostend, 8400
Study site
Oudenaarde, 9700
Study site
Roeselare, 8800
Study site
Ronse, 9600
Study site
Seraing, 4100
Study site
Sint-Niklaas, 9100
Study site
Tongeren, 3700
Study site
Turnhout, 2300
Study site
Verviers, 4800
Study site
Wilrijk, 2610
About this study
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
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).
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice
Measured: approximately 24 months
Secondary outcomes (5)
Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice
Measured: approximately 24 months
Safety: Incidence of adverse events/adverse events of special interest
Measured: approximately 24 months
Clinical/demographic patient characteristics at baseline
Measured: approximately 24 months
Dosage/regimen
Measured: approximately 24 months
Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment
Measured: approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startAug 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676922
- Sponsor's protocol ID
- ML27768
- Status last verified
- Nov 2016
- First submitted
- 27 Aug 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01676922
- Acronym / sponsor ID
- ML27768
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients >/= 70 years of age with previously untreated metastatic colorectal cancer suitable to receive chemotherapy with or without Avastin
Key inclusion criteria (3 listed)
- Adult patients, >/ 70 years of age
- Previously untreated metastatic colorectal cancer
- Patient considered suitable to receive chemotherapy with or without Avastin
Key exclusion criteria (1 listed)
- Participation in any other clinical trial or study with the exception of participation in registries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice
Time frame: approximately 24 months
5 secondary outcomes
Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice
Time frame: approximately 24 months
Safety: Incidence of adverse events/adverse events of special interest
Time frame: approximately 24 months
Clinical/demographic patient characteristics at baseline
Time frame: approximately 24 months
Dosage/regimen
Time frame: approximately 24 months
Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment
Time frame: approximately 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 33 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice (time frame: approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.