Colorectal CancerNCT01775644
An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)
An observational study of Colorectal Cancer, run by Hoffmann-La Roche.
Trial summary
This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed. 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?
- Bevacizumab
- How many people
- 3,003 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2012to 10 May 2019
- 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 metastatic colorectal cancer
Who may be able to join
- Participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC)
Who cannot join
- Contraindications for bevacizumab according to SmPC
About this study
Official title: Avastin ® First Line and Where Applicable Beyond First Progression With Metastatic Colorectal Carcinoma
This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.
- Conditions
- Colorectal Cancer
- Being tested
- Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Administration of treatment will be as used in normal daily routine under local labeling.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Colorectal Cancer Participants | Administration of treatment will be as used in normal daily routine under local labelling in 4 subgroups- participants with liver and/or lung metastases, potentially resectable after a response to a systemic therapy and clinically operable; participants with tumor related symptoms, risks for complications or fast progression for whom quick proliferation control is needed; "asymptomatic" participants (indolent tumor) without the option of a metastases resection (no pressure for remission) for whom the aim of the therapy is proliferation control and participants without classification. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST)
Measured: Baseline up to 5 years
Secondary outcomes (22)
Percentage of Participants by Prognostic Factors
Measured: Baseline up to 5 years
Percentage of Participants by Carcinoembryonic Antigen Tumor Marker
Measured: Baseline
Percentage of Participants by Cancer Antigen 19-9 Tumor Marker
Measured: Baseline
Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status
Measured: Baseline
Percentage of Participants by Comorbidity Index as per Carlson Method
Measured: Baseline
Percentage of Participants by RAS Mutation Status
Measured: Baseline
Percentage of Participants by Cancer Metastasation Status
Measured: Baseline
Percentage of Participants According to Previous Treatment Regimen of Bevacizumab
Measured: Baseline
Progression-Free Survival as Assessed by RECIST (Overall)
Measured: Baseline up to 5 years
Overall Survival in Daily Routine Practice
Measured: Baseline up to 5 years
Overall Survival in Defined Participant Subgroups in Daily Routine Practice
Measured: Baseline up to 5 years
Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST
Measured: Baseline up to 5 years
Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice
Measured: Baseline up to 5 years
Number of Participants With Adverse Event
Measured: Baseline up to 5 years
Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups
Measured: Baseline up to 5 years
Total Cumulative Therapy Dose of Bevacizumab
Measured: Baseline up to 5 years
Percentage of Participants With Treatment Success
Measured: Baseline up to 5 years
Percentage of Participants With Resection
Measured: Baseline up to 5 years
Number of Physicians Satisfied With Treatment
Measured: Baseline up to 5 years
Percentage of Participants Without Resection by Reason
Measured: Baseline up to 5 years
Percentage of Participants With Follow-Up therapy
Measured: Baseline up to 5 years
Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST
Measured: Baseline up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study start14 Dec 2012
- Primary completion10 May 2019
- Study completion10 May 2019
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
- 3,003 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
- NCT01775644
- Sponsor's protocol ID
- ML28120
- Status last verified
- Nov 2021
- First submitted
- 23 Jan 2013
- Last updated
- 2 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avastin ® First Line and Where Applicable Beyond First Progression With Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT01775644
- Acronym / sponsor ID
- ML28120
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,003 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2012 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 25 Jan 2013 (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 multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Colorectal Cancer Participants | – | Drug: BevacizumabAdministration of treatment will be as used in normal daily routine under local labelling in 4 subgroups- participants with liver and/or lung metastases, potentially resectable after a response to a systemic therapy and clinically operable; participants with tumor related symptoms, risks for complications or fast progression for whom quick proliferation control is needed; "asymptomatic" participants (indolent tumor) without the option of a metastases resection (no pressure for remission) for whom the aim of the therapy is proliferation control and participants without classification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with metastatic colorectal cancer
Key inclusion criteria (1 listed)
- Participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC)
Key exclusion criteria (1 listed)
- Contraindications for bevacizumab according to SmPC
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 |
|---|---|---|
| BevacizumabAlso: AvastinAdministration of treatment will be as used in normal daily routine under local labeling. | Drug | Metastatic Colorectal Cancer Participants |
Primary outcome
Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST)
Time frame: Baseline up to 5 years
22 secondary outcomes
Percentage of Participants by Prognostic Factors
Time frame: Baseline up to 5 years
Percentage of Participants by Carcinoembryonic Antigen Tumor Marker
Time frame: Baseline
Percentage of Participants by Cancer Antigen 19-9 Tumor Marker
Time frame: Baseline
Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Baseline
Percentage of Participants by Comorbidity Index as per Carlson Method
Time frame: Baseline
Percentage of Participants by RAS Mutation Status
Time frame: Baseline
Percentage of Participants by Cancer Metastasation Status
Time frame: Baseline
Percentage of Participants According to Previous Treatment Regimen of Bevacizumab
Time frame: Baseline
Progression-Free Survival as Assessed by RECIST (Overall)
Time frame: Baseline up to 5 years
Overall Survival in Daily Routine Practice
Time frame: Baseline up to 5 years
Overall Survival in Defined Participant Subgroups in Daily Routine Practice
Time frame: Baseline up to 5 years
Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST
Time frame: Baseline up to 5 years
Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice
Time frame: Baseline up to 5 years
Number of Participants With Adverse Event
Time frame: Baseline up to 5 years
Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups
Time frame: Baseline up to 5 years
Total Cumulative Therapy Dose of Bevacizumab
Time frame: Baseline up to 5 years
Percentage of Participants With Treatment Success
Time frame: Baseline up to 5 years
Percentage of Participants With Resection
Time frame: Baseline up to 5 years
Number of Physicians Satisfied With Treatment
Time frame: Baseline up to 5 years
Percentage of Participants Without Resection by Reason
Time frame: Baseline up to 5 years
Percentage of Participants With Follow-Up therapy
Time frame: Baseline up to 5 years
Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST
Time frame: Baseline up to 5 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 2 Dec 2021.
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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
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 1 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 Dec 2021. 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?
Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST) (time frame: Baseline up to 5 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 2 Dec 2021.