Metastatic Colorectal CancerNCT02542436
Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in Normal Clinical Use in the UK Population
An observational study of Metastatic Colorectal Cancer, run by Hoffmann-La Roche.
Trial summary
This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Dec 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 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
- Have been diagnosed with metastatic colorectal cancer (mCRC)
- Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment
- Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer
- Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab
- Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom
- For Cohort 1 (post CDF funding availability): patients between 2010-2013 who received bevacizumab with first-line chemotherapy
- For Cohort 2 (pre Cancer Drugs Fund [CDF] funding availability): patients propensity matched to cohort 1 between 2005-2008 who did not receive bevacizumab with first-line chemotherapy
Who cannot join
- Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial
- Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study
About this study
Official title: An Observational Study to Investigate the Real World Effectiveness of Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in the UK
This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- No intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention administered in this study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: bevacizumab | Participants with metastatic colorectal cancer between 2010-2013, who received bevacizumab (25 mg/ml concentrate for solution for infusion) with first-line chemotherapy. Receives: Other: No intervention | |
| Cohort 2: no bevacizumab | Participants with metastatic colorectal cancer between 2005-2008, who did not receive bevacizumab with first-line chemotherapy. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: From date of metastatic colorectal cancer diagnosis to date of death up to 3 years
Secondary outcomes (3)
Response Rate (RR)
Measured: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Progression Free Survival (PFS)
Measured: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Percentage of Participants with Adverse Events of Special Interest
Measured: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start1 Sep 2015 (estimated)
- Primary completion31 Dec 2015 (estimated)
- Study completion31 Dec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Retrospective
- Enrolment
- 0 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
- NCT02542436
- Sponsor's protocol ID
- ML29965
- Status last verified
- Sep 2017
- First submitted
- 2 Sep 2015
- Last updated
- 13 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Investigate the Real World Effectiveness of Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in the UK
- ClinicalTrials.gov ID
- NCT02542436
- Acronym / sponsor ID
- ML29965
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2015 (estimated)
- Primary completion
- 31 Dec 2015 (estimated)
- Study completion
- 31 Dec 2015 (estimated)
- First posted
- 7 Sep 2015 (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 study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: bevacizumab | – | Other: No interventionParticipants with metastatic colorectal cancer between 2010-2013, who received bevacizumab (25 mg/ml concentrate for solution for infusion) with first-line chemotherapy. |
| Cohort 2: no bevacizumab | – | Other: No interventionParticipants with metastatic colorectal cancer between 2005-2008, who did not receive bevacizumab with first-line chemotherapy. |
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 (7 listed)
- Have been diagnosed with metastatic colorectal cancer (mCRC)
- Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment
- Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer
- Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab
- Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom
Key exclusion criteria (2 listed)
- Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial
- Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study
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 |
|---|---|---|
| No interventionNo intervention administered in this study | Other | Cohort 1: bevacizumab, Cohort 2: no bevacizumab |
Primary outcome
Overall Survival (OS)
Time frame: From date of metastatic colorectal cancer diagnosis to date of death up to 3 years
3 secondary outcomes
Response Rate (RR)
Time frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Progression Free Survival (PFS)
Time frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Percentage of Participants with Adverse Events of Special Interest
Time frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
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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 Metastatic 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 7 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Sep 2017. 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 was withdrawn before enrolling participants, so there are no results.
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) (time frame: From date of metastatic colorectal cancer diagnosis to date of death up to 3 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 13 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.