Colorectal CancerNCT02831842
A Real World Study to Evaluate Effectiveness of Avastin (Bevacizumab) for First Line Treatment of Patients With Metastatic Colorectal Cancer and Known KRAS Status
An observational study of Colorectal Cancer, run by Hoffmann-La Roche.
Trial summary
This non-interventional study will meta-analyze overall survival outcomes among the participants with metastatic colorectal cancer (mCRC) with available V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) status, who received firstline treatment with bevacizumab containing treatment regimen in routine clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Anti-EGFR-Containing Regimen, Bevacizumab-containing regimen and Chemotherapy
- How many people
- 4,278 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2016to 30 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with mCRC and known KRAS status who received bevacizumab as first-line treatment.
Who may be able to join
- Participants with metstatic colorectal cancer (mCRC) diagnosed at any point prior to March 2014 (United States [US] - Vector Oncology Protocol Sponsored by US Roche Pharma Medical Affairs), diagnosed between September 2006 and March 2015 (Germany - Tumourregister Kolorektales Karzinom [TKK] Registry Study Supported by German Roche Pharma Affiliate), diagnosed between September 2009 and December 2014 (Australia - Treatment of Recurrent and Advanced Colorectal Cancer [TRACC] Registry Supported by Roche Pharma Australia), diagnosed between 2009 and 2013 (Denmark - Roche Diagnostic Sponsored Study and Aarhus University Hospital, Department of Clinical Epidemiology)
- Participants have been treated in first line with bevacizumab or Anti-EGFR treatment regimen or chemotherapy alone
- Participants have to have available data on overall survival (OS), KRAS testing status, and left/right tumor location status
Who cannot join
- N/A
About this study
Official title: A Non-Interventional Multi-country Study to Evaluate the Real World Effectiveness of Avastin (Bevacizumab) for First Line Treatment of Patients With Metastatic Colorectal Cancer and Known KRAS Status
This non-interventional study will meta-analyze overall survival outcomes among the participants with metastatic colorectal cancer (mCRC) with available V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) status, who received firstline treatment with bevacizumab containing treatment regimen in routine clinical practice. The study leveraging secondary data from existing cohorts in the United Stats of America (USA), Germany, Australia, and Denmark.
- Conditions
- Colorectal Cancer
- Being tested
- Anti-EGFR-Containing Regimen, Bevacizumab-containing regimen, Chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-EGFR-Containing RegimenDrug
Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.
Bevacizumab-containing regimenDrug
Also called Avastin
Study protocol does not specify any particular bevacizumab containing regimen. The data will be collected retrospectively.
ChemotherapyDrug
Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.
| Study group | Role | What they receive |
|---|---|---|
| mCRC Participants | Data of mCRC participants who received first-line treatment with bevacizumab-containing regimen or with chemotherapy alone and had KRAS-mutant status and mCRC participants who received first-line treatment with bevacizumab-containing regimen or an anti-epidermal growth factor receptor (EGFR)-containing regimen and had KRAS wild type status, will be collected retrospectively. Receives: Drug: Anti-EGFR-Containing Regimen; Drug: Bevacizumab-containing regimen; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) in Participants With mCRC and a Documented KRAS Mutation who Received Bevacizumab-Containing Treatment or Chemotherapy Alone in Routine Clinical Practice
Measured: start of first-line therapy to death from any cause, or to last date known that participant is alive (retrospective data collection over approximately 9 years)
Secondary outcomes (1)
OS in Participants With mCRC and a Documented KRAS Wild Type Status who Received Bevacizumab-Containing Treatment or Anti-EGFR Treatment in Routine Clinical Practice
Measured: start of first-line therapy to death from any cause, or to last date known that participant is alive (retrospective data collection over approximately 9 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start9 Jun 2016
- Primary completion9 Jun 2016
- Study completion30 Nov 2017
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
- 4,278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Germany: PEI Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831842
- Sponsor's protocol ID
- MO30177
- Status last verified
- Jan 2018
- First submitted
- 12 Jul 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Multi-country Study to Evaluate the Real World Effectiveness of Avastin (Bevacizumab) for First Line Treatment of Patients With Metastatic Colorectal Cancer and Known KRAS Status
- ClinicalTrials.gov ID
- NCT02831842
- Acronym / sponsor ID
- MO30177
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,278 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2016 (actual)
- Primary completion
- 9 Jun 2016 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 13 Jul 2016 (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 non-interventional study will meta-analyze overall survival outcomes among the participants with metastatic colorectal cancer (mCRC) with available V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) status, who received firstline treatment with bevacizumab containing treatment regimen in routine clinical practice. The study leveraging secondary data from existing cohorts in the United Stats of America (USA), Germany, Australia, and Denmark.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCRC Participants | – | Drug: Anti-EGFR-Containing Regimen, Drug: Bevacizumab-containing regimen, Drug: ChemotherapyData of mCRC participants who received first-line treatment with bevacizumab-containing regimen or with chemotherapy alone and had KRAS-mutant status and mCRC participants who received first-line treatment with bevacizumab-containing regimen or an anti-epidermal growth factor receptor (EGFR)-containing regimen and had KRAS wild type status, will be collected retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with mCRC and known KRAS status who received bevacizumab as first-line treatment.
Key inclusion criteria (3 listed)
- Participants with metstatic colorectal cancer (mCRC) diagnosed at any point prior to March 2014 (United States [US] - Vector Oncology Protocol Sponsored by US Roche Pharma Medical Affairs), diagnosed between September 2006 and March 2015 (Germany - Tumourregister Kolorektales Karzinom [TKK] Registry Study Supported by German Roche Pharma Affiliate), diagnosed between September 2009 and December 2014 (Australia - Treatment of Recurrent and Advanced Colorectal Cancer [TRACC] Registry Supported by Roche Pharma Australia), diagnosed between 2009 and 2013 (Denmark - Roche Diagnostic Sponsored Study and Aarhus University Hospital, Department of Clinical Epidemiology)
- Participants have been treated in first line with bevacizumab or Anti-EGFR treatment regimen or chemotherapy alone
- Participants have to have available data on overall survival (OS), KRAS testing status, and left/right tumor location status
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-EGFR-Containing RegimenStudy protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively. | Drug | mCRC Participants |
| Bevacizumab-containing regimenAlso: AvastinStudy protocol does not specify any particular bevacizumab containing regimen. The data will be collected retrospectively. | Drug | mCRC Participants |
| ChemotherapyStudy protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively. | Drug | mCRC Participants |
Primary outcome
Overall Survival (OS) in Participants With mCRC and a Documented KRAS Mutation who Received Bevacizumab-Containing Treatment or Chemotherapy Alone in Routine Clinical Practice
Time frame: start of first-line therapy to death from any cause, or to last date known that participant is alive (retrospective data collection over approximately 9 years)
1 secondary outcome
OS in Participants With mCRC and a Documented KRAS Wild Type Status who Received Bevacizumab-Containing Treatment or Anti-EGFR Treatment in Routine Clinical Practice
Time frame: start of first-line therapy to death from any cause, or to last date known that participant is alive (retrospective data collection over approximately 9 years)
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 26 Jan 2018.
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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.
Germany: PEI Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hoffmann-La Roche.
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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall Survival (OS) in Participants With mCRC and a Documented KRAS Mutation who Received Bevacizumab-Containing Treatment or Chemotherapy Alone in Routine Clinical Practice (time frame: start of first-line therapy to death from any cause, or to last date known that participant is alive (retrospective data collection over approximately 9 years)). 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 26 Jan 2018.